|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030054 S173/ PAS001 |
| Date Original Protocol Accepted |
11/29/2011
|
| Date Current Protocol Accepted |
03/02/2012
|
| Study Name |
QUAD PAS
|
| Device Name |
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
|
| 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 |
Prospective multi-center study
|
| Study Population |
Patients can be approached in one of two ways for enrollment:
¿ Through patient participation in the Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study (IDE Study patients); or
¿ Through participating centers with newly implanted patients.
|
| Sample Size |
1,884 new patients will be enrolled to achieve an evaluable sample size of 1,036 patients. In addition, patients will be included for total sample size. 80 active centers enrolled in this study.
|
| Key Study Endpoints |
Primary endpoints: to estimate:
¿ Freedom from system-related complications through 5 years.
¿ Freedom from system-related complications through 5 years.
¿ Mean of programmed LV lead pacing capture threshold across 10 pacing configurations at 5 years.
Secondary endpoints: To characterize the complication rate of the Quartet Model 1458 LV Lead and to perform a trend analysis of all complications.
|
| Follow-up Visits and Length of Follow-up |
All patients will have a total duration of follow-up of 5 years from the
date of implant
Patients who have a successful system implant will be seen at 6
months (+ 45 days) after implant and every 6 months (+ 60 days)
thereafter until the patient reaches the 5 year visit.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1,970
|
| Actual Number of Sites Enrolled |
71
|
| Patient Follow-up Rate |
796 completed at 5 year follow up
|
| Final Safety Findings |
The freedom from complications rate is 89.6%, which exceeds the 80% primary endpoint 1.
There was no significant difference between the IDE rollover and newly enrolled subjects regarding freedom from system-related complications through 5 years. The freedom from lead complications rate is 95.9%, which exceeds the 92.5% primary endpoint 2. Primary lead complication is dislodgement. None of the deaths were related to the system.
|
| Final Effect Findings |
Mean lead pacing capture threshold met endpoint 3.
|
| Study Strengths & Weaknesses |
This is a prospective, multicenter study that provides long term data up to 5 years on the safety and effectiveness of the device. The study outcomes are positive. The follow up rate was a challenge.
|
| Recommendations for Labeling Changes |
The labeling will be updated based on the 5 year safety and effectiveness results reported in the PAS final report.
|
