Conduction System Pacing With INGEVITY+

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1383 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-13

Study Completion Date

2024-08-27

Brief Summary

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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).

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Detailed Description

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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

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Bradycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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LBBA INGEVITY+ Pacing

Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA.

Cardiac pacing

Intervention Type DEVICE

Patient's previously implanted with the INGEVITY+ lead located in the LBBA

Interventions

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Cardiac pacing

Patient's previously implanted with the INGEVITY+ lead located in the LBBA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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