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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Long Term


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General
Study Status Completed
Application Number P030054 / PAS001
Date Current Protocol Accepted  
Study Name Long Term
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study was designed to collect, characterize and report on the performance of the device system through three years post-implant.
Study Population Description The study included patients rolled over from the pre-market study and newly enrolled post-approval study patients.
Sample Size 1,121 patients, 46 sites
Data Collection Endpoints include all-cause mortality for patients implanted with CRT-D or CRT-P systems; Freedom from LV lead or LV lead implant procedure related adverse events; Electrical performance of the LV leads
Follow-up Visits and Length of Follow-up Patients will be followed every six months for 3 years
Interim or Final Data Summary
Interim Safety Information Study completed, see final results.
Actual Number of Patients Enrolled 1127 patients
Actual Number of Sites Enrolled 46 sites
Patient Follow-up Rate 73%
Final Safety Findings The freedom from all-cause mortality for patients implanted with CRT-D systems is 80% at 3 years. The freedom from LV lead or procedure-related complications is 94% at 3 years. The freedom from system-related complications is 89% at 3 years. The reviews by the lead reviewer and clinical reviewershow that these rates are consistent with expectations and that the 20% mortality is not unexpected given the high proportion of class III and IV heart failure patients.
Study Strengths & Weaknesses Strength: Large sample size which allows for the examination of rarer events Limitation: Allowance for inclusion of IDE study participants. There was a substantial difference in the major outcomes (death, HF events, etc) between the subjects who were rolled in from the IDE and the newly enrolled PAS subjects (who faired notably worse). This substantial difference seems to be independent of the covariates that were looked at and so it may be concerning. One likely explanation for the difference is of selection bias. The subjects rolled in from the IDE had already been free of death and presumably major events before they enrolled in the PAS and so may have been overall less likely to have events compared to the newly enrolled subjects. But even if selection bias explains the difference, it seems to me that the results for the newly enrolled subjects is a better representation of real world outcomes.
Recommendations for Labeling Changes None


Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
42 month report 12/29/2007 02/01/2008 Overdue/Received
Final Report 04/15/2009 04/15/2009 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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