|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P950037 S156/ PAS001 |
Date Original Protocol Accepted |
06/08/2016
|
Date Current Protocol Accepted |
04/15/2019
|
Study Name |
Siello Pacing Lead Study
|
Device Name |
SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60
|
Clinical Trial Number(s) |
NCT01791127
|
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 |
Actual Number of Patients Enrolled |
1,015 patients implanted with a Siello lead on or between March 13, 2013 and July 20, 2015.
|
Actual Number of Sites Enrolled |
N/A
|
Patient Follow-up Rate |
N/A
|
Final Safety Findings |
There were a total of 33 complications identified in 33 out of 1,841 Siello leads as attributable or possible attributable to the device. Of the 1174 evaluable patients for this endpoint, there were 33 Siello leads with a qualifying event, resulting in an CFR of 97.19%.
|
Final Effect Findings |
N/A
|
Study Strengths & Weaknesses |
This study’s use of real-world data captures a large representative assessment of device performance. While data granularity is limited, the study confirms there are no significant safety concerns with the device’s long term performance.
|
Recommendations for Labeling Changes |
Yes
|