Medtronic InSync biventral pacing system registry study

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General
Application Number / P010015
Current Protocol Accepted / 08/28/2001
Study Name / Registry
Study Status / Completed
General Study Protocol Parameters
Study Design / Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) / Yes
Data Source / Sponsor Registry
Comparison Group / No Control
Analysis Type / Descriptive
Study Population / Adult: >21
Detailed Study Protocol Parameters
Study Design Description / This is a non-randomized multi-center registry. The purpose of this study is to characterize the
Study Population Description / Study Populaton: Patients from the completed Multicenter InSync Randomized Clinical Evaluation (MIRACLE), U.S. InSync III
Sample Size / Up to 2000 patients may be enrolled to obatin 1000 patients with 3 years of follow-up, 150 sites
Data Collection / The primary endpoints include 1) mortality and cause specific mortality, 2) Left ventricular sensing: biventricular
Followup Visits and Length of Followup / Clinical data is collected at baseline and then every 6 months for 36 months or
Final Study Results
Actual Number of Patients Enrolled / 1,999
Actual Number of Sites Enrolled / 99
Patient Followup Rate / One-thousand and fourteen patients reached 3 years follow-up and attrition is 49.3%. Of the 985
Final Safety Findings / The event-free proportion at 3-years was 89.5% with 425 patients at risk. The 36-month estimate
Final Effectiveness Findings / The proportion of patients with elevated thresholds through 36-months was 15.96% (models 2187/2188/4193/4194) and 8.02%
Study Strengths and 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

Registry Schedule

Report Schedule
/ Report
Date Due
/ FDA Receipt
Date
/ Reporting Status
PAS Interim Report / 02/27/2008 / 02/27/2008 / On Time
7 year report / 08/28/2008 / 08/26/2008 / On Time
8 year report / 08/28/2009 / 08/28/2009 / On Time
9 year report / 08/28/2010 / 08/24/2010 / On Time
10 year report-final report / 08/28/2011 / 06/27/2011 / On Time

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Page Last Updated: 11/02/2015