Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D

Recruiting

• Conditions: Ventricular Tachycardia (VT); Ventricular Fibrillation

• Registration Number: NCT06745778
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:

• Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Study Start: 2025-02-26
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients aged >=18 yrs.
• Patients indicated for ICD or CRT-D (primary or secondary prevention)
• Patients who recently (<=30 days) received ICD/CRT-D implantation with LBBP
• Patients' EGM can be digitally recorded
• Patients are willing to participate in the study and provide signed informed consent

Exclusion Criteria

• Patients received CIED upgrade or replacement with old pacing leads
• Patients are pregnant
• Patients participate in another study that will confound this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R-wave amplitude of LBB EGM	At the enrollment, 3 months after enrollment and 6 months after enrollment	Amplitude in millivolt

Secondary Outcome Measures

Name	Time	Method
EGM morphology-LVAT	At the enrollment, 3 months after enrollment and 6 months after enrollment	LVAT in millisecond, calculated based on electrogram recorded by LBB lead

Trial Locations

Locations (2)

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Shanghai Tongren Hospital; 🇨🇳 Shanghai, China