Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014866
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-25
First Post:
2023-08-22
Brief Title:
Conduction System Pacing With INGEVITY
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
ConductIoN System pacInG witH IngeviTy for the Left Bundle Branch Area
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
None
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?:
None