ML20133P480
| ML20133P480 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 07/01/1975 |
| From: | BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | |
| Shared Package | |
| ML20133P439 | List: |
| References | |
| PROC-750701, NUDOCS 8511010026 | |
| Download: ML20133P480 (23) | |
Text
Page 24 (Attachment 3)
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V
, HUMAN CLINICAL PROTOCOL for THE CORATOMIC C-100 SERIES i
of RADIOISOTOPE POWERED CARDIAC PACERS
. JULY 1,1975 F
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_ BOX 434, INDIANA, PENNA.,15701. _ _ _. _ _ _ _ _
C ORATOMIC, INC.
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(412) 349-1811 0
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t Page 25 (Attachment 3) r Table of Contents V
Subjeci:
Pg 1.
Investigational Program Purpose 1
2.
Description of the Pacer and Radionuclide Power Source 1
3 Patient Selection 2
4.
Implantation Time Period 2
5.
Follow-up and Reporting 2
6 Patient Control Group 3
7 Implantation Procedures and Leads 3
8 Stimulation Threshold Measurements 3
9.
Sensing Threshold Measurements 3
10.
Registration and Implant Reports 5
11.
Follow-up Data 6
12.
Data and Reports of' Removal and Replacement 6
i
- 13. Notification of Deaths, Adverse Reactions or Malfunctions 6
- 14. Notification of Loss of Patient Contact 6
15.
Information To and Consent From the Patient 6
- 16. Record Retention 7
)
Exhibit I
- References 8
Exhibit II
- Registration and Implantation Data Fom 9
Exhibit III - Follow-Up Data Form 11 Exhibit IV
- Pacer Failure and Removal or Patient Death Form 12 Exhibit V
- Infomed Consent for Surgical Implantation of Radioisotope 13 Powered Cardiac Pacer 4
Exhibit VI
- Patient Identification Cards 15 Exhibit VII - Donor Cards for Adults 16 Exhibit VIII - Donor Cards for Minors 17 s
Exhibit IX
- Instructions for Hospital or Clinic Telephone Operators 18 Er.hibit X
- Suggested Application Format For Nuclear Powered Pacemakers 19 O
i
- 9 CORATOMIC C-100 SERIES RADI0IS0 TOPE CARDIAC PACER PROTOCOL (Attachment 3)
July 1, 1975 1.
Investigational Program 3
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The purpose of the Coratomic C-100 Series Investigational Program is to obtain statistical data under controlled conditions to determine the reliability, efficacy and longevity of the C-100 Series of Pacers.
Its objective is also to provide greater increased longevity compared to standard pacers and prolonged relief from consequences of symptomatic bradycardia for those patients receiving the C-190 Series of Pacers.
2.
Description of the Pacers and Radionuclide Pacer Source The totally implanted, battery powered cardiac pacer has been in clinical use since 1960, and is now the selected method of treatment for heart block and other forms of symptomatic bradycardia.
It is also used in selected cases of symtomatic tachyarrhythmias. An extensive literature has arisen in connection with cardiac pacing, and selected references are listed in Exhibit 1.
The physician responsible for this study is cognizant of these and other relevant references, and has had extensive experience in the use of cardiac pacers.
The C-100 Series of Pacers are R-wave inhibited demand pacers with a projected life of greater than 20 years. They are electronically similar to demand pacers which have been in use far many years.
The series consists of two models, the C-100 and the C-101.
The C-100 is extremely insensitive to electromagnetic inter-ference and skeletal muscle artifact signals. These are picked up between the anode or case of the pacer and the electrode tip located in the heart.
If the anode is adjacent to the pectoralis, for example, as the pectoralis flexes it creates a voltage which may reseable a broad R-wave, which might inhibit the pacer as does a normally occurring R-wave. The C-100, in order to discriminate against
{V these external signals has a fairly narrow bandpass and relatively insensitive N
inout amplifier, which allows it to sense R-waves only.
The C-101 on the other hand inas bem designed to be more sensitive and to have a broader bandpass since in certain patients their broad, low amplitude R-waves will be insufficient to allow the C-100 to effectively sense. Thus, this unit should be used when the C-100 is known to be unable to effectively sense, which can be determined by the use of the C-100 evaluator. The C-100 evaluator must be used prior to the implant of a C-100 to assure that the C-100 can sense the patients R-wave. A description of the evaluator and its use is given under Section 9, Sensing Threshold Measurements. The pacers provide a nominal 72 beat per minute pulse rate when the patient's R-wave is not sensed, and are inhibited when the R-wave is sensed. The units are hermetically sealed and shielded against electromagnetic interference. They have an asynchrcnous
" magnet rate" of 90 beats per minute, used to ascertain cardiac capture and for operational verification, and will switch to the same fixed rate rather than becoming inhibited if high energy electromagnetic fields are present.
The fuel used for the C-100 Series of Pacers is plutonium-238 in its oxide form, pressed and sintered into a hard, ceramic pellet. The isotopic battery has been so designed that excess electrical power is available at the end of a 20 year life. The parers have undergone extensive testing for efficacy, including excessive mechanical shock, ig act, and vibration testing, and the nuclear fuel is contained in such a manner to prevent fuel release under any credible accident, including building or auto accident, fire, fall from an airplane, crushing, corrosion in sea water, or accidental cremation.
Data concerning radiation level, safety, and efficacy testing is on file with the United States Nuclear Regulatory Comission, as a Master Protocol.
The C-100 Pacer has been used in dogs since September 1973, and animal testina to assure higher reliability is continuing as part of Coratomic's data gathering and licensing program.
Page 27 F'
(Attachment 3) i 3.
Patient Selection I
The patients to be selected for this clinical study will be those who f))
have heart block or other form of symptomatic bradycardia requiring an im-l0 V planted pacer. The physician will select patients who have a life expect-ancy of at least ten
- and preferably twenty years, in order to obtain a maximum amount of data concerning longevity and reliability of the unit.
An influential factor, however, other than longevity is that the small size and weight of the Coratomic unit may enhance the longevity of the patient compared to other pacemakers, and data on all age groups will, therefore, be of value since additional variables other than life expectancy are important in the C-100 series test. For example, the smaller size and weight of the unit may be statistically significant in reducing pressure necrosis, lead failure or other volume and shape induced failures unknown at this time.
For this reason, life expectancy alone, although still significant, is not as dominant a factor as in the use of other nuclear pacemakers heretofore licensed for clinical applications, and patients with a life expectancy less than 20 years should form part of the statistical sample.
In certain cases, also, the physician may judge the use of the C-100 series to be caramount in prolor.ging life in an older patient who has had many previous operations, or is resistant to frequent operations, or is not mentally capable of handling a rechargeable unit.
In these cases, expected to be a small percentage, the physician may use his dis-cretion in implanting the C-100 series units.
From a statistical point of view only, it would be ideal if the distri-bution of patients with C-100 series pacers were weighted in the same manner as the general pacer population, thus providing the most accurate statistical data where the greater number of patients with pacers exist. An attempt will be (d
made to skew the total pacer population in this manner by continued feedback and communication between individual physicians, and the statistical correla-tion center at Coratomic.
Patients whose life expectancies are limited to less than 10 years by reason of co-existing diseases will, except for conditions of extreme need, be excluded from this study. Cooperative and reliable patients, who are stable and non-mobile members of the community will be selected to assure accurate long-term follow-up reporting and study.
4.
Implantation Time Period The clinical implantation period discussed in this protocol will continue for two years, at which time this study will have completed its implantation period. All patients will be monitored until the death of the patient or removal of the pacer.
5.
Follow-Up and Reporting A careful follow-up and reporting procedure will be followed during the life of the patient or until the pacer is removed. At each examination period an electrocardiogram will be obtained, with and without the application of a p()
- The 1971 Life Insurance Fact Book Institute of Life Insurance, New York, N. Y.,
Page 107, indicates that in the U. S. total population the life expectancy of a 72 year old is 10.27 years. ;
Page 28 (Attachment 3) magnet to induce fixed rate operation of the pacer. The following examination in time after implant will be followed as closely as possible:
24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />,1 week,1 month, 3 months and 6 month intervals thereafter until re-()'
moval. Telephone transmission and testing of pulse intervals is an acceptable
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method of testing.
It is recognized that general medical care may be more frequent than this, but this is the minimal time between tests of pacer func-tion by the study clinic, or responsible physician.
6.
Patient Control Group A reference control group, identified as closely as possible in age, sex, stability and diagnosis will be used. An attempt should be made to include in this group pacer systems using lithium or rechargeable nickel cadmium batteries to provide comparative data on other potentially long lived systems. The nunter of patients in this group should be equal to the C-100 series group. All data and information collected from this group will be identical to that obtained with the C-100 series of pacers. All patients in the control group will have unipolar electrodes and have R-wave inhibited electronics powered by conven-tional sources currently available.
7.
Implantation Procedures and leads Ccaventional methods of pacemaker insertion are to be used, ensuring as far as possible that the electrodes and leads used have an expected life com-parable to the pacemaker and that they have appropriate pacing thresholds.
In patients with an existing lead, the type of existing electrode must be com-patible.
If not, standard adaptors may be used. Spliced leads may not be used.
Ideally, the Coratomic C-100 series leads should be utilized to assure long-term
(
compatibility with the pacer materials. Myocardial or endocardial leads may be used with any of the standard surgical approaches for lead implantation in
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either the left or the right ventricle.
The C-100 series pulse generators may be im-planted in the subcutaneous t:ssue of the abdomen, chest wall, the subpectoral muscular tissue of the chest wall, or any other area deemed suitable by the responsible physician.
8.
Stimulation Threshold Measurements The pacing threshold will be tested for all electrodes, old or new, utilizing a battery operated, calibrated ( 5% accuracy) pulse generator with an adjustable amplitude and of a pulse duration of.8 to 1.2 milliseconds.
Only those electrodes may be utilized in which a threshold is demonstrated no greater than 1.5 ma if newly implanted or 4.0 ma if chronically implanted, whether transvenous or epicardial, measured at a pulse width of 1.0 milliseconds 9.
Sensing Threshold Measurements Since the C-100 pacer has a relatively high threshold for sensing, i.e.,
voltages below this sensing threshold will not be detected by the C-100 and recognized ~
as normal R-waves, an evaluator is provided with the C-100 to assure that the opera-tion of the C-100 will be adequate in patients who have broad low amplitude R-waves.
The C-100 evaluator is designed with an attenuation factor to assure that the C-100 will continue to function even though the patient's R-wave may change, as has been reported in Reference 5.
A photograph of the evaluator is shown in Figure 1.
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When the Coratomic C-100 Evaluator is used with the following procedure, effective sensing and pacing will occur with the C-100.
If the C-100 Evaluator l
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C-100 Evaluator, C-100 Plug-In Connector and Ground Plate Figure 1,
Page 30 (Attachment 3) b (V
indicates that the C-100 pacemaker should not be used, the C-101, a more sensitive pacemaker, should be used, a.
Depress the green battery test button seen on ti left of the evaluator in Figure 1.
If the green light above the greer..utton glows, the batteries are known to be sufficiently strong to operate 1.he electronics.
A standard 9 volt battery, similar to the Eveready Model #216 the RCA Model dVS-323, the Mallory Model SM-1604 or equivalent is used, b.
The Coratomic groundplate,also shown in Figure 1, should be placed in the surgical pocket prepared by the surgeon for insertion of the C-100 pacer.
The black lead should then be connected to the groundplate in the surgical pocket, the leads having been previously sterilized, either by ethylene oxide, zephirin, or autoclaving. The pin end of the black lead is inserted into the black terminal on the evaluator, thereby connect-i ing the anode or groundplate, which simulates the anode of the pacer, to i
the ground terminal of the evaluator.
c.
The red lead is connected to the end of the previously implanted cardiac lead and the pin of the red lead is inserted into the red terminal on the Evaluator-- the red lead also being previously sterilized. This connects the electrode to the electronic circuitry in the same manner as the electrode would be connected to the C-100 pacer, and thus the Evaluator now sees the same electrical environment that the C-100 or C-101 pacer will see when
)
implanted.
d.
Depress the red test button at the right side of the evaluator.
If the red light above the button flashes in synchronism with the patient's R-wave, effective sensing is occurring and, thus, proper sensing will occur when the Coratomic C-100 Pacemaker is implanted.
The button should be depressed for approximately one second to allow the electronics to stabilize before observing the flashing.
If sensing by the C-100 will not occur, the red indicator light will glow at a very low level of brightness, but no flash-ing will eccur.
If the red light does not flash in synchronism with the patient's R-wave, the C-100 should not be used, and the C-101 should be used in place of the C-100.
This is because its sensitivity is much greater than the C-100, i.e., it will sense much lower amplitude and broader R-waves than the C-100.
It is anticipated that approximately 5 percent of the patients will require the C-101 pacer, due to its greater sensitivity.
10.
Registration and Implant Reports Imediately upon implantation of the C-100 series, the physician or hospital
'll complete a Registration and Implant Data Fonn, and forward it, within 10 to the Coratomic Data Center. The fann includes identification of the
.naker, the patient, the physician, the hospital, the heart lead, and adapter
,(if used), stimulated rate, and clinical data concerning the patient and his or her cardiac disease. The data form is shown as Exhibit II, attached.
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Page 31 1
(Attachment 3) l
- 11. Follow-up Data The follow-up data, reported at intervals as discussed in 5 above,
)
" Follow-up and Reporting", will be prepared by the investigator and submitted to the Coratomic Data Center on the Follow-up Data Form. This form is attached, v
(Exhibit III) and provides information on the patient, C-100 series pacer function ano a brief clinical history of the patient including laboratory data, adverse reactions to the implanted device, if any, a description of the re-actions and opinions as to the nature and major cause of the reactions, and an evaluation of the efficacy of the device and procedure.
- 12. Data and Reports of Removal and Replacement Removal and Replacement constitutes particularly significant data, and therefore, a special fom, " Pacer Failure and Removal or Patient Death", is provided, Exhibit IV. This form has all pertinent required data concerning the patient, investigator, hospital, and reasons for removal and replacement including whether the failure was of battery, electronic, or lead origin.
Corrective procedures and results of patient examinations are also required.
- 13. Notification of Deaths, Adverse Reactions or Malfunctions Notification of death is included in the form, " Pacer Failure and Removal or Patient Death", shown in Exhibit IV. The cause of death and autopsy find-ings are included.
- 14. Notification of Loss of Patient Contact
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This notification is included in the Follow-up Data Form, Exhibit III.
(
The reasons for loss of contact and steps taken to reestablish contact are included.
If loss of contact is reported on this form, Caratomic, with data provided in the initial implant form, Exhibit II, will attempt to pursue the patient until a satisfactory explanation or terminus of the lost pacer case is provided.
- 15. Information To and Consent From the Patient a.
All patients will be completely informed about the nature of the clinical trial by the investigator, and to confirm this communication, will sign the informed consent fom (Exhibit V). They will be informed of alter-native procedures, b.
All patients accepting the pacemaker must agree to the follow-up scheme sumarized above and to the removal and return to the physician (and from them to Coratomic) of the unit upon the completion of its expected useful life (20 years), its failure, or upon the patients death, whichever occurs first. A legally binding document (Exhibit V) will be signed by the patient, a witness, his spouse, and/or a relative of the patient.
c.
The patient will be required to carry an identification card as stated in "
the form shown in Exhibit V.
This card is shown in Exhibit VI. The card will identify the carrier as a radioisotope powered cardiac pacer patient, will specify the manufacturer and model number of the subjects pacemaker, p
specify the radionclides contained in the pacer, and present explicit t!
i
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Page 32 (Attachment 3) instructions for notification of responsible parties in the event of accident or difficulty. The patient will also be required to carry a s
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uniform anatomical Gift Act Card, as shown in Exhibit VII.
If the patient
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has not attained majority age, the agreemsat card shown in Exhibit VIII should be executed by the patient where possible and his or her legal guardian.
d.
The patient will also be required to carry an identification bracelet of the medical-alert type which will carry the same patient's name and a statement to call the proper emergency telephone and physician in emergency.
This bracelet is mentioned in Exhibits III and IV, e.
The patient will participate in follow-up examinations as discussed in 5 above, 'and he will be required to agree to do so on the informed consent form of Exhibit V.
f.
The patient will notify the hospital of any change in address or contact and will be' required to agree to do so on the informed consent form of Exhibit V.
g.
The patient will be required to notify the hospital of his intention to travel in foreign countries. The hospital will, in turn notify Coratomic, who will notify the Nuclear Regulatory Commission. The patient grees to pro-vide this information on the informed consent form (Exhibit V
- 16. Record Retention
- )
All pacer records will be maintained separately from the rountine hospital i
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records, either by a centralized authority so designated, health physics per-sonnel, or the pacemaker clinic within the hospital's jurisdiction, or the physician responsible for the study.
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Page 33 (Attachment 3)
EXHIBIT I (1
x REFERENCES C--
1.
Smyth, Nicholas P. D.: Cardiac Pacemaking. Surgical Disea:es of the Chest, Second Edition in Press, Editor Brian Blades., C. V. Mosby Co.
St. Louis, Mo., 1974.
2.
Chardack, William M.:
Cardiac Pacemakers and Heart Block.
In Surgery of the Chest (Chapter 38), Second Edition, Editors John H. Gibson, Jr.,
David C. Sabiston and Frank C. Spencer.
W. B. Saunders Co., Philadelphia, Pa., 1969.
3.
Furman, Seymour, and Escher, Doris J. W.:
Principles and Techniques of Cardiac Pacing. Harper and Row, New York, N.Y., 1970.
4.
Thalen, Hilbert J.: The Artificial Cardiac Pacemaker:
Its History, Development and Clinical Application. C. C. Thomas, Springfield, Ill.,
1969.
5.
Hurzeler, Philip; Decaprio, Vincent; and Furman, Seymour, Montefiore Hospital and Medical Center, New York, N.Y.:
Endocardial Electrograms and Pacer Sensinc ; paper presented at AMil 10th Annual meeting March 17-18, 1975.
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EXHIBIT II Page 34
\\
REGISTRATION AND IMPLANTATION DATA FORM (Attachment 3)
CORATOMIC C-100 SERIES ISOTOPIC PULSE GENERATOR j
Please complete this form.
Retain one copy for your records and return [within 10 days]
^
one copy to:
CORATOMIC, INCORPORATED DATA CENTER P. O. Box 434 Indiana, Pennsylvania 15701 (please print or type) 1.
Patient Name Last First Initial Social Security No.
Hospital Record No.
Home Address City State Zip Area Code and Telephone No.
Business Address City State Zip Area Code and Telephone Co.
Name, address, and telephone of person (s) to be contacted if patient cannot be located:
City State Zip
.f Area Code and Telephone No.
1/
Relationship to Patient Name, address, and telephone of alternate person (s) to be contacted if patient cannot be located:
City State Zip Area Code and Telepnone No.
Relationship to Patient 2.
Physician (s) and Hospital:
Name Office Address City State Zip Area Code and Telephone No.
3.
Radioisotope Powered Pacer Information:
Model No.
Serial No.
Date of Implant Placement:
s u b c u ta n eou s / s u bmu s c u l a r/ i n t r a mu s c u l a r/ o th er right/left pectoral / abdominal /other l
existing /new pocket i
Stimulation rate: with Magnet without Threshold measurements: voltage current Pulse width other method (describe):
Equipment used to measure threshold Page 35 EXHIBIT II - (Continu:d)
(Attachment 3) 4.
Previous Implant Information:
Yes/No If yes:
N Manufacturer
.)
Model Date of implant Why removed Total number of previous implants 5.
Lead:
Manufacturer Model No.
Serial No. (for new leads only)
Date of implant Placement:Myocardial: right/left ventricle I
transthoracic /transmediastinal Endocardial: vein used Previous leads (if applicable and available):
Myocardial: Number, models, and implant dates; how many removed?
i Endocardial: Number, models, and implant dates; how many removed?
t 6.
Clinical data:
Patient's age Sex Race Height Weight Right handed /Left handed Etiology of arrhythmia i
Kind of arrhythmia Previous drug therapy for arrhythmia Associated diseases Temporary pacing (for initial implants only) yes/no Anesthetics used during surgery Antibiotics:
locally / systemically /none Cortisones or other anti-inflamatory drugs:
locally / systemically /none Was pocket drained: yes/no If yes, how long?
Did complications or adverse reaction occur in:
pacemaker / lead surgery If yes, treatment
- Coments, i
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a 1 i
Page 36 i
EXHILIT III (Attachment 3)
FOLLOW-UP DATA FORM CORATOMIC C-100 SERIES ISOTOPIC PULSE GENERATOR
(./
Please complete this form. Retain one copy for your records and return one copy to:
i CORATOMIC INCORPORATED DATA CENTER Box 434 Indiana, Pa. 15701 l
1.
Patient Name i
Last First Ini tiai Social Security No.
Patient Hospital Record No.
Pulse Generator Model No.
Serial No.
Date of Implantation Date of Follow-up Name of Physician Name of Hospital Telephone No.
Address L
City State Zip i
Patient has I.D. Card:
Yes No l
Patient is wearing Bracelet or its Equivalent:
Yes No 2.
C-100 Series Pacer Information Satisfactory Stimulation Rate - with Magnet without Magnet es Unsatisfactory V
Description of adverse reactions Nature and cause of adverse reaction Description of side effects Toxicity Contraindications Ina'fectiveness Pacer malfunction Pacer degradation Has any repair, relocation or replacement of leads been necessary?
Yes No 3.
Has satisfactory contact been maintained with the patient for follow-up and accountability purposes? Yes No If no, why was contact lost?
f What steps have been taken to re-establish contact?
4.
Summary of medical examination, including laboratory data (at yearly intervals-
, l
Page 37 (Attachment 3)
EXHIBIT IV PACER F AILURE AND REMOVAL OR PATIENT DEATH FORM CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR Please complete this fom. Retain one copy for your records and return one copy to:
CORATOMIC, INCORPORATED DATA CENTER Box 434 Indiana, Pa. 15701 1.
Patient Name Last First Initial Social Security No.
i Patient Hospital Record No.
Pulse Generator Model t'!o.
Serial flo.
Date of Implantation Date of Follow-up Name of Physician Name of Hospital Telephone No.
Address l
City State Zip Patient has I.D. Card:
Yes fio Patient is wearing Bracelet of its Equivalent:
Yes No 2.
Pacer Failure O
Battery Failure Lead Failure Electronics Failure Description of Failure Corrective Procedure Due to Failure Replaced Pacer Model and Serial f; umber of Replacement Replaced Lead Model and Serial 11 umber of Replacement Lead 3.
Patient Death Causes of Death Autopsy Findings Was pacer functioning at time of death? Yes flo Was lead functioning at time of death? Yes No 4.
Sumary of Medical Examinations (if other than death)
O Page 38 EXHIBIT V (Attachment 3)
INFORMED CONSENT FOR SURGICAL IMPLANTATION A
0F RADI0IS0 TOPE P0WERED CARDIAC PACER CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR I understand that for the treatment of my cardiac condition--a disturbance of nonnal cardiac conduction--a cardiac pacer is to be implanted in me.
I under-stand that the surgical procedure may/will require the implantation of a new electrode or lead into or onto the surface of my heart. While the surgical pro-cedure is not of unreasonable risk, the possibility of complications or even death exist. The procedure has been explained to me, and I have had the opportunity to ask any questions concerning it.
I understand that the pacer to be used for the implantation is a radioisotope powered cardiac pacer manufactured by Coratomic.
The pacer is now undergoing its initial clinical use. Although the pacer has been extensively tested, it is of relatively new design, and there is no assurance that its components will last the full design life. On the basis of experiments in animals and in the laboratory, units of this type are expected to have a reliable life expectancy in excess of that of current standard carC ac pacers.
I understand that the cardiac pacer does produce radiation, but I he been told by my attending physician that it is his medical judgment that this radiation presents a negligible hazard.
I understand that in consenting to the implantation of this pacer, I am authorizing, as well, all standard operating procedures, including the adminis-tration of anesthetics which may be incident to the operation.
For the purpose of advancing medical and scientific knowledge, I consent to the admittance of observers p) to the operating room.
1, Since the device contains radioisotope material (Plutonium-238), ultimately, after my death or earlier, if the useful life of the pacer is exceeded, if it ceases to function effectively for my medical needs, or if I request to have it removed, the pacer must be returned to Coratomic via (licensed institution).
Accordingly, I agree to contact (institution) at regular intervals of no less than six nonths, and whenever I change my residence.
I will always carry the appropriate identification card on my person, and will at all times wear the standard Idcatification bracelet.
Notwithstanding my contacting the implanting institution following the in-sertion of a cardiac pacer of any sort, I am advised to remain in contact with my personal physician.
Since the use of radioisotope powered pacers is governed by agreements between the Nuclear Regulatory Commission of various countries I agree to notify the hospital, who will, in turn, notify Coratomic of my intention to travel in foreign countries.
Coratomic will. in turn, notify the Nuclear Regulatory Commission.
I understand that the radioisotope powered cardiacpacer is a highlytechnical prosthetic device and in order to assess the effectiveness ofits use, (institution) and Coratomic areinterested in collecting data upon the device. Accordingly, I agree to visit the institution in person or to transmit by telephone (with the aid of a device loaned to me and applied to the surface of my skin) my electrocardiogram as
- O an indication of the functioning of the pacer. This will be at no less than the W
l I
Page 39 (Attachment 3) following intervals:
at 1 month, 3 months and 6 month intervals,thereafter,following the X insertion of the pacer.
I further agree to provide infomation on my clinical
) condition as it pertains to the pacer at no less than S-month intervals. Further-('~' more, I consent to disclosure by the clinic or Coratomic of any information acquired by the clinic in regard to the implantation of the radioisotope powered cardiac pacer, provided, however, in no event shall disclosure other than to Coratomic include my identification without my specific written approval.
I have had the opportunity to ask questions pertaining to the surgical procedure, the radioisotope powered cardiac pacer, and the follow-up procedure.
The possible alternate methods of treatment, including the use of conventional chemical battery powered pacers and rechargeable pacers have been called to my attention.
With these facts in mind and intending to be legally bound, I hereby authorize the surgical procedure whereby the Coratomic radioisotope powered pacer will be implanted in me waiving the right to claim that such procedure was not properly authorized, and I agree to the follow-up procedures and to the ultimate return of the unit as detailed above.
Witness (Date)
Patient's signature or person (Date) authorized to consent for the f) patient.
v Re nationship to the patient signing if other than the patient.
I certify that I have explained the above procedure Please sign 3 copies:
1 copy to patient 1 copy to hospital 1 copy to Coratomic Dr.
(Date)
Page 40 EXHIBIT Vi PATIENT IDENTIFICATION CARDS CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATORS (Front)
N 1 MAVI AN luPLANTED CORATOmlC SADIC150f0P8 PQwitt3 CARDIAC PACER If CONTAfMS LIS$ D AN 43 CWRif t OF PLUTCNsum 338. GOVERNMENT R(GULAflON$ REQQlti PACEE REMOVAL AND tifuRN UPON ORAfN.
I E
o"nNUS CA$'$'~C$INEA [u'CYa#03 PaCit PHYllCIAN a
ADetg55 PMON5 aD (Back)
COI1 ATOMIC, INC.
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P. O. 50X A34 BNOBANA, PA. l$3) (413) 349.1819 NAALS ADQtli$
C:ff SIAff
!lP PHONE
$QC. IIC. NO.
PACES AnCCEL SttlAL HQ.
CAff OP (MPLANT Pact RAfg TYPE OP LtA0
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Page 41 (Attachment 3)
EXHIBIT VII
'X' DONOR CARDS FOR AD' LTS J
U CORATOMIC C-101 SERIES IS0 TOPIC PULSE GENERATOR (Front) s O CORATOMIC,INC.
P. O. SCI A34, INDIANA, PA. 15708 (4125 349 1811 DONOR CARD FOR ADULTS Pa NT ce nPE NAmt Of DOMOa IN CONS:Ot#Afr0N FOR THE fMPLANTATION IN Mt CF A C-100 PACES AS fN 6 A sti A EGF T
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(Back)
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Page 42 EXHIBIT VIII (Attachment 3)
DONOR CARDS FOR MINORS D
CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR 1
(Front) 4 m.O CORATOMIC.INC.
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Page 43 EXHIBIT IX (Attachment 3)
INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR Project Nuclear Pacemaker Instructions to Operator:
1.
Accept any collect call with reference to " Project Nuclear Pacemaker".
2.
Any call concerning " Project Nuclear Pacemaker" involves a patient with a nuclear pacer and requires immediate action to insure that there is no danger of radiation exposure and recovery of the nuclear pacer.
3.
Obtain at much infomation from the caller as is possible including:
Caller's Name and Where he may be Reached, j
Patient's Name, Status, and Where he may be Reached.
I Attending Physician (if any) and Where he may be Reached.
Infomation from Patient I.D. Card Patient's Social Security No.
f Date of Implant Pacer Serial Number 4.
Notify imediately: _
i (Name, address, telephone number of pnysician responsible for study)
If he cannot be reached, notify:
Name, address, telephone number of alternative physician.
If neither can be reached, contact physician on duty for the Ct.rdiac Care Unit; inform him that this involves a nuclear pacer; and advise him of the information you have and the urgency of the matter.
2 0
1 Page 44 EXHIBIT X (Attachment 3)
SUGGESTED APPLICATION FORMAT FOR NUCLEAR POWERED PACEMAKERS CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR C/
Chief, Materials Branch Division of Materials and Fuel Cycle Facility Licensing U. S. Nuclear Regulatory Comission Washington, D. C.
20545 Re: Application for license to participate in the research study involving the implantation of Coratomic C-100 Series nuclear powered pacemakers, each containing 250 milligrams of Pu-238 (<4.3 curies).
Gentlemen:
The following information is submitted in application for a license to participate in the investigational program utilizing the Coratomic C-100 nuclear powered pacer.
1.
Applicant:
(Hospital or Medical Institution)
(Aidress)
)
v (State and Zip Code) 2.
Physicians responsible for study:
(Provide this information for each physician on the study team.)
Name:
Office Address:
Telephone Number:
State Licensed in Which to Practi ce:
Specialty Board Certification:
Position with the Applicant:
Previous experience in the clinical implantation and follow-up of pacemakers by physicians; (include duration of pacemaker experience, total number of implants physician has done, and the total number he has done at the applicant's facilities. )
9 f
Page 45 (Attachment 3)
EXHIBIT X (Continued)
A 3.
Protocol to be followed:
I HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C-100 SERIES RADI0 ISOTOPE
(
POWERED CARDIAC PACERS DATED JULY l,1975.
4.
A maximum of Coratomic C-100 series paccmakers is requested to be implanted annually during the study.
5.
Description of physical facilities and equipment at tha applicant institution or hospital:
(Include description of cardiac care unit and operating facilities and list specific equipment needed and available to carry out the study; include. equipment for measuring stimulation thresholds, threshold parameters, and overall pacemaker function).
6.
Description of applicant's present pacemaker inplantation and follow-up program:
(Include size, i.e., number of patients, and duration.)
7.
Describe methods applicant will establish to maintain records of implantation and follow-up of patients sep.arate from routine hospital records.
(Include procedures for assuring continuity of follow-up and detemining any possible loss of follow-up with a patient).
8.
Confim that the applicant institution or hospital will establish appropriate centrol procedures to insure the physical security of (n
the pacemaker while in the possession of the applicant. These
)
procedures will include keeping track, by serial number, of the location of each pacemaker and requiring that they be kept under lock and key when not being used to guard against loss or theft.
Confirm that all activities will be conducted in accordance with the regulations under Title 10, Code of Federal Regulations, Part 70.
9.
Describe the applicants procedures to assure notification of appropriate individuals upon receipt of an emergency report of inquiry concerning a pacemaker bearer.
Include written instructions to be given to telephone operators.
10.
Confirm that the physicians responsible for and participating in the study represent that they are familiar with Coratomic C-100 Series Protocol and the Coratomic C-100 Series Pacer and understand that the issuance of a license is conditional upon the following of this protocol.
11.
Confim that the applicant institution agrees to continue the follow-up reporting ai recovery procedures during the life of the patient and until the pacmaker is recovered and returned to Coratomic, Inc.,
P.O. Box 434, Indiana, Pa. 15701, even in the event the physicians named in the application to participate in the study are no longer associated with the applicant.
12.
Confim that packaging, labeling, and sF-ping instructions to be furnished by Coratomic Inc. will be foiiowed upon the return of the pacemaker for approved disposal.
Page 46
.(Attachment 3)
EXHIBIT X (Coniinued) 13.
The applicant hospital or medical institution hereby requests a license to receive, possess, store. and implant the Coratomic C-100 Series nuclear powered pacemaker ir. accordance with this application.
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Signed:
l Applicant:
(Hospital or Medical Institution) j By:
j (name and title of individ-ual signing on behalf of j
theapplicant) i i
Physicians responsible for study:
(letter should be signed by both an officer of the applicant and the physicians responsible for the study.
Type or print names under signatures.)
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