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

Medtronic

Status: Enrolling

Conditions: Ventricular Tachycardia (VT); Ventricular Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT06745778

LBBP-ICD study

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

ICD or CRT-D patients who have received LBBP implantation

Description:

Patients' EGMs can be recorded by Holter DR220