|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P070008 S079/ PAS001 |
Date Original Protocol Accepted |
05/04/2017
|
Date Current Protocol Accepted |
09/24/2019
|
Study Name |
QP ExCELS Sentus QP Ext CRT w/ Quad LV
|
Device Name |
PACEMAKER ICD CRT NON IMPLANTED COMPONENTS
|
Clinical Trial Number(s) |
NCT02290028
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Descriptive
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Confirm long-term safety of the Biotronik Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 5 years post-implant.
|
Study Population |
CRT-eligible Heart Failure patients
|
Sample Size |
Postmarket Sample Size Required: 979 Postmarket Sample Size Required including attrition = 1754
|
Key Study Endpoints |
Primary Endpoint: The purpose is to evaluate the long-term Sentus related complication-free rate through 5 years post-implant.
|
Follow-up Visits and Length of Follow-up |
5 years
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
2872
|
Actual Number of Sites Enrolled |
N/A - RWE
|
Patient Follow-up Rate |
N/A - RWE
|
Final Safety Findings |
Primary safety objective of complication-free rate (CFR) greater than 92.5% at 5 years post-implant for Sentus LV leads was met. 84 complications noted in 2920 Sentus leads. Lower bound of the two-sided 95% confidence interval of CFR was 92.72%.
|
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 |
Labeling changes should include the study design, results, and strengths and weaknesses of the PAS.
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