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Conduction System Pacing With INGEVITY+ | Clinical Trials | Clareo Health

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COMPLETEDNCT06014866

Conduction System Pacing With INGEVITY+

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).

Lead sponsor: Duke University•8 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Duke University

Collaborators

Boston Scientific Corporation

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.

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

No

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

Exclusion Criteria

•ICD and CRT-D devices

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 23, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment1,383

Start dateNov 2023

Last updatedMay 23, 2025

Condition

Locations shown

Sarasota Memorial Health Care System

Sarasota, Florida

University of Chicago

Chicago, Illinois

Community Heart And Vascular Hospital

Indianapolis, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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