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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010015 / PAS001 |
| Date Original Protocol Accepted |
08/28/2001
|
| Date Current Protocol Accepted |
08/28/2001
|
| Study Name |
Registry
|
| Device Name |
MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM
|
| 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 non-randomized multi-center registry. The purpose of this study is to characterize the postmarket performance of the InSync Model 8040 (InSync), InSync III Model 8042 (InSync III), Attain LV leads (Models 2187, 2188, OTW 4193, OTW 4194), InSync ICD Model 7272, InSync Marquis Model 7277, InSync II Marquis Model 7289, InSync Maximo Model 7303, and InSync Sentry Model 7297.
|
| Study Population |
Study Populaton: Patients from the completed Multicenter InSync Randomized Clinical Evaluation (MIRACLE), U.S. InSync III trials, and patients implanted after market release approval of the InSync, InSync III CRT, and CRT-D systems may be enrolled into the InSync Registry.
|
| Sample Size |
Up to 2000 patients may be enrolled to obatin 1000 patients with 3 years of follow-up, 150 sites
|
| Key Study Endpoints |
The primary endpoints include 1) mortality and cause specific mortality, 2) Left ventricular sensing: biventricular pacing impedance, biventricular R wave amplitude (sensing), and LV pacing voltage threshold, and 3) lead-related complications.
|
| Follow-up Visits and Length of Follow-up |
Clinical data is collected at baseline and then every 6 months for 36 months or until explant or death.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1,999
|
| Actual Number of Sites Enrolled |
99
|
| Patient Follow-up Rate |
One-thousand and fourteen patients reached 3 years follow-up and attrition is 49.3%. Of the 985 study exits, 450 (46%) were patient deaths.
|
| Final Safety Findings |
The event-free proportion at 3-years was 89.5% with 425 patients at risk. The 36-month estimate is 89.8% with 555 patients at risk.
|
| Final Effect Findings |
The proportion of patients with elevated thresholds through 36-months was 15.96% (models 2187/2188/4193/4194) and 8.02% (model 4194).
The proportion of patients with elevated thresholds through 36-months was 15.96% (models 2187/2188/4193/4194) and 8.02% (model 4194).
The proportion of patients with impedance out of range was 0% through 36 months for both lead models.
The proportion of patients with an R-wave out-of-range through 36-months was 1.01% (models 2187/2188/4193/4194) and 0.63% (model 4194).
|
| Study Strengths & Weaknesses |
One-thousand and fourteen patients reached 3 years follow-up and attrition is 49.3%. Of the 985 study exits, 450 (46%) were patient deaths. The high attrition introduces bias into the study results and limits the external validity.
|
| Recommendations for Labeling Changes |
Yes, the sponsor will be asked to include a summary of the post-approval study methods and results specifically presenting a frequency histogram of various lead capture outcome values for the InSync registry to be included in the manuals for the applicable devices
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