Conduction System Pacing With INGEVITY+ (INSIGHT-LBBA)

Duke University

Status

Completed

Conditions

Bradycardia

Treatments

Device: Cardiac pacing

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06014866

Pro00113475

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,383 patients

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Primary Analysis:

De novo anti-bradycardia pacing pacemaker implant.
INGEVITY+ lead implant attempt in the LBBA as documented in the medical record at least 90 days ago.
LBBAP implant attempt employed a Boston Scientific SSPC series sheath

Exclusion Criteria for Primary Analysis:

-ICD and CRT-D devices