Conduction System Pacing With INGEVITY+ (INSIGHT-LBBA)

May 20, 2025 updated by: Duke University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1383

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34233
        • Sarasota Memorial Health Care System
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Community Heart and Vascular Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health - Saint Mary's Duluth Clinic
    • New York
      • Flushing, New York, United States, 11355
        • NewYork-Presbyterian Queens
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • TriHealth Bethesda North Hospital
    • Texas
      • Sugar Land, Texas, United States, 77479
        • Houston Methodist Sugar Land Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients implanted with an INGEVITY+ lead implanted in the LBBA to provide rate support for bradycardia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LBBA INGEVITY+ Pacing
Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA.
Device: Cardiac pacing
Patient's previously implanted with the INGEVITY+ lead located in the LBBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead-Related Complication Free Rate
Time Frame: Implant through 90 days
Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.
Implant through 90 days
Pacing Threshold
Time Frame: Implant through 90 days
Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.
Implant through 90 days
Sensed R-wave amplitude
Time Frame: Implant through 90 days
Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.
Implant through 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Daniel Friedman, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Actual)

August 27, 2024

Study Completion (Actual)

August 27, 2024

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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