NCT06014866

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2024

Completed
Last Updated

May 23, 2025

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

August 22, 2023

Last Update Submit

May 20, 2025

Conditions

Bradycardia

Keywords

Conduction system pacingCardiac physiologic pacing

Outcome Measures

Primary Outcomes (3)

  • Lead-Related Complication Free Rate

    Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.

    Implant through 90 days

  • Pacing Threshold

    Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.

    Implant through 90 days

  • Sensed R-wave amplitude

    Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.

    Implant through 90 days

Study Arms (1)

LBBA INGEVITY+ Pacing

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

Device: Cardiac pacing

Interventions

Cardiac pacingDEVICE

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

LBBA INGEVITY+ Pacing

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • ICD and CRT-D devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sarasota Memorial Health Care System

Sarasota, Florida, 34233, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Community Heart And Vascular Hospital

Indianapolis, Indiana, 46227, United States

Location

Essentia Health - Saint Mary's Duluth Clinic

Duluth, Minnesota, 55805, United States

Location

NewYork-Presbyterian Queens

Flushing, New York, 11355, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

TriHealth Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479, United States

Location

Related Publications (1)

  • Friedman DJ, Shadrin I, Goldbarg S, Trulock KM, Patel A, Loring Z, Coles SA, Gandhi G, Upadhyay GA, Wold N, Jones PW, Ruble SB, Weinstock J, Latanich CA. Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA. Heart Rhythm. 2025 Aug;22(8):2047-2054. doi: 10.1016/j.hrthm.2025.01.041. Epub 2025 Feb 4.

    PMID: 39914662RESULT

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Friedman, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

November 13, 2023

Primary Completion

August 27, 2024

Study Completion

August 27, 2024

Last Updated

May 23, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(8)