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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P940008 / PAS001
Date Original Protocol Accepted 11/28/1995
Date Current Protocol Accepted  
Study Name PAS
Device Name RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a registry-based study that includes all patients who have received the Res-Q Automatic Implantable Cardioverter Defibrillator System (ACD) Model 101-01 and 101-01R Epicardial Patch and Non-thoracotomy Lead System.The purpose of the registry is to monitor the performance of the epicardial lead system post-PMA approval.
Study Population The study proposed to follow the patient population enrolled in the RES Q ACD PATCH protocol to monitor the performance of the epicardial patch leads. This proposal is for the patient population enrolled in the Res Q ACD PATCH protocol IDE 900143 implanted with Res-Q/ Res-Q Micron ICD Models . These are patients who are at high risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: (1) survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmia, or (2) recurrent, poorly tolerated sustained ventricular tachycardia. There were 16 patients eligible for postmarket follow-up.
Sample Size 16 patients eligible for postmarket follow-up
Key Study Endpoints The data endpoints were actuarial lead survival (lead failures) and fatal events.
Follow-up Visits and Length of Follow-up Patients are assessed periodically (approximately every 4 months) and data is reported annually .
Interim or Final Data Summary
Actual Number of Patients Enrolled 16 patients eligible for postmarket follow-up.
Actual Number of Sites Enrolled unknown
Patient Follow-up Rate 15/16 had their devices removed from service or are deceased, the remaining patient has been lost to follow-up. No patients were followed-up.
Final Safety Findings The final report did not include statistical analysis for this study since there is only one patient remaining in the study.
Study Strengths & Weaknesses Weakness: The report does not include statistical analysis for this study since there is only one patient remaining in the study.
Recommendations for Labeling Changes None


PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Annual Report 11/27/2007 11/27/2007 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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