Trials / Completed
CompletedNCT06014866
Conduction System Pacing With INGEVITY+
ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,383 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 1 Day
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cardiac pacing | Patient's previously implanted with the INGEVITY+ lead located in the LBBA |
Timeline
- Start date
- 2023-11-13
- Primary completion
- 2024-08-27
- Completion
- 2024-08-27
- First posted
- 2023-08-28
- Last updated
- 2025-05-23
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06014866. Inclusion in this directory is not an endorsement.