Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT06014866
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2023-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conduction System Pacing With INGEVITY+
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSIGHT-LBBA
Brief Summary:
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
Detailed Description:
INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide complication free rate (safety) and lead measurements (performance).
Data will be gathered by means of a retrospective, multi-center, US only observational chart review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing thresholds and R-wave amplitude. Consecutive implants will be collected from each site for evaluating the endpoints.
Data will be gathered by means of a retrospective, multi-center, US only observational chart review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing thresholds and R-wave amplitude. Consecutive implants will be collected from each site for evaluating the endpoints.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: