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Completed

NCT Number: NCT06014866

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).

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sarasota Memorial Health Care System, Sarasota, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac pacing

Device

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

Primary outcomes

  1. 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.

  2. Pacing Threshold

    Time frame: Implant through 90 days

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

  3. Sensed R-wave amplitude

    Time frame: Implant through 90 days

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: INSIGHT-LBBA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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