Conduction System Pacing With INGEVITY+

Bradycardia Clinical Trial

— INSIGHT-LBBA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06014866
• Other study ID #: Pro00113475
• Status: Enrolling by invitation
• Start date: November 13, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: September 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Cardiac pacing
Patient's previously implanted with the INGEVITY+ lead located in the LBBA

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pacing Threshold	Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.	Implant through 90 days
Primary	Sensed R-wave amplitude	Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.	Implant through 90 days