Conduction System Pacing With INGEVITY+

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06014866

Acronym

INSIGHT-LBBA

Enrollment

1383

Registered

2023-08-28

Start date

2023-11-13

Completion date

2024-08-27

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

Keywords

Conduction system pacing, Cardiac physiologic pacing

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).

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.

Interventions

DEVICECardiac pacing

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026