|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P150012 S083/ PAS001 |
Date Original Protocol Accepted |
12/16/2019
|
Date Current Protocol Accepted |
06/19/2020
|
Study Name |
INGEVITY+ Post Approval Study
|
Device Name |
Ingevity + Lead - Active Fixation
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
The INGEVITY+ Clinical Study is a prospective, non-randomized, multi-center, post-market study.
|
Study Population |
This is a one-armed study where every subject is assigned to treatment, where treatment means implanted, or attempted implant of INGEVITY+ leads in the right atrium and ventricle.
|
Sample Size |
At least 105 subjects will be enrolled in the study to achieve 200 implanted or attempted leads.
The study will include approximately 20 sites in North America.
|
Key Study Endpoints |
Primary Safety Endpoint: Lead-related complication-free rate from implant through 3-months post-implant
Primary Effectiveness Endpoint: Pacing capture threshold at 3-months post-implant
Secondary Effectiveness Endpoint: Sensed amplitude and pacing impedance at 3-months post-implant
|
Follow-up Visits and Length of Follow-up |
The study duration for each subject is expected to be approximately 3 months. Subjects will be exited from the study after their 3 month visit.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
109
|
Actual Number of Sites Enrolled |
13
|
Patient Follow-up Rate |
One hundred and ninety-eight (198) leads among one hundred (100) subjects have completed either the 3-month visit or 91 days of follow-up. One hundred and one (101) subjects have completed the 3-month follow-up visit.
|
Final Safety Findings |
The lead-related complication-free rate from lead implant to 3 months for all leads was 98.5%, with a lower confidence limit of 95.4%.
|
Final Effect Findings |
As of the date of the report snapshot, 98.9% of leads (184 of 186) have reported a pacing capture threshold less than or equal to 2V with a 0.4ms pulse width.
|
Study Strengths & Weaknesses |
The safety endpoint through 3 months of follow-up was met. All effectiveness endpoints at 3 months of follow-up were met. The data confirms the safety and effectiveness of the INGEVITY+ lead.
|
Recommendations for Labeling Changes |
no
|