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Conduction System Pacing With INGEVITY+

ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area

NCT06014866•Duke University

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.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (8)

Sarasota Memorial Health Care System

Sarasota, Florida, United States

University of Chicago

Chicago, Illinois, United States

Community Heart And Vascular Hospital

Indianapolis, Indiana, United States

Essentia Health - Saint Mary's Duluth Clinic

Duluth, Minnesota, United States

NewYork-Presbyterian Queens

Flushing, New York, United States

Duke University

Durham, North Carolina, United States

TriHealth Bethesda North Hospital

Cincinnati, Ohio, United States

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, United States

Key Dates

Start Date

November 13, 2023

Primary Completion Date

August 27, 2024

Completion Date

August 27, 2024

Last Updated

May 23, 2025

Enrollment

1,383

ACTUAL participants

Conditions

Bradycardia

Interventions

Cardiac pacing

DEVICE

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

NCT07221682

Post Operative AnalgesiaBradycardia+1 more

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RECRUITING

His Bundle Pacing in Bradycardia and Heart Failure

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BradycardiaHeart Failure

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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: March 29, 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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Conduction System Pacing With INGEVITY+

Inclusion Criteria

Exclusion Criteria

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

His Bundle Pacing in Bradycardia and Heart Failure

Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery