|
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.
|