f Post-Approval Studies (PAS) Database
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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		 P980003 / PAS001
Date Original Protocol Accepted 02/02/1999
Date Current Protocol Accepted  
Study Name PAS
Device Name CHILLI COOLED RF ABLATION SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This was a one-armed, observational, prospective cohort study, the purpose of which was to compare device safety and effectiveness with objective performance criteria.
Study Population The study population was patients for whom the Chilli device is indicated, who had failed or were intolerant to drug therapy.
Sample Size 200 patients, 19 sites
Key Study Endpoints Effectiveness Endpoints: ventricular tachycardia recurrence rate, defined as the percent of subjects with one or more episodes of ventricular tachycardia recurrence within six months following the index procedure. Safety Endpoints: Assessed as the occurrence rate of a procedure-related major adverse event within seven days of the index procedure.
Follow-up Visits and Length of Follow-up Endpoints were assessed at 6-months post-implant
Interim or Final Data Summary
Actual Number of Patients Enrolled 182 patients
Actual Number of Sites Enrolled 19 sites
Patient Follow-up Rate 88%
Final Safety Findings The primary effectiveness goal was not met. The success criteria was a ventricular tachycardia recurrence rate of 54.2%, whereas the upper 95% confidence limit was 63.8%
Study Strengths & Weaknesses Strength: Propensity analysis was conducted to control for confounding variables; Weakness: It is unclear whether to OPCs, on which the success criteria were based, were appropriate.
Recommendations for Labeling Changes Labeling changes were made to reflect the failure to meet part of the success criteria.


PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final PAS Report 04/26/2007 04/26/2007 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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