|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P050023 S076/ PAS001 |
Date Original Protocol Accepted |
07/03/2014
|
Date Current Protocol Accepted |
04/15/2019
|
Study Name |
Protego DF4 Post Approval Registry
|
Device Name |
ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Admin Database
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
This study is designed to gather safety data on BIOTRONIK’s lead using active monitoring of Medicare fee-for-service (FFS) claims data. The design is a prospective, single-arm, non-randomized, observational cohort study utilizing real world data.
|
Study Population |
Patients who are implanted with the lead and are in the beneficiary match population for the claims data are included in the patient population.
|
Sample Size |
750 minimum evaluable sample required to demonstrate superiority to a complication-free rate of 92.5%.
|
Key Study Endpoints |
The purpose of primary endpoint 1 is to evaluate the overall incidence of complications attributable to the lead through 5 years post-implant.
|
Follow-up Visits and Length of Follow-up |
5 years post-implant
|
Interim or Final Data Summary |
Interim Results |
Th
|
Actual Number of Patients Enrolled |
A total of 2,702 patients implanted with 2,721 Protego leads met all study inclusion and no study exclusion criteria and are included in the Protego claims cohort for this final report. Overall, 37.10% (2,702/7,283) of patients implanted with a Protego lead during the PAS enrollment period were matched as unique beneficiaries in the CMS database and had both FFS Medicare coverage during the month of the Protego lead implant and a Medicare claim during the analysis period.
|
Actual Number of Sites Enrolled |
N/A
|
Patient Follow-up Rate |
N/A
|
Final Safety Findings |
56 complications were identified to meet the primary endpoint. The estimated freedom from complications at 1,802 days is 97.18%, meeting 5 year rate >92.5%. There were no DF4 header connector malfunctions.
|
Final Effect Findings |
N/A
|
Study Strengths & Weaknesses |
The study successfully enrolled and matched patients to Administrative Claims data, permitting larger enrollments than traditional post approval study clinical follow up. Since event rates were rare, the CMS cell suppression policy does not permit additional granular information to be included.
|
Recommendations for Labeling Changes |
Yes
|