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

Recruiting now

Conditions studied: Ventricular Tachycardia (VT), Ventricular Fibrillation

In brief

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.

Key facts

Study ID

NCT06745778

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

50

Starts

2025-02-26

Expected to finish

2026-07-31

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
• Shanghai Tongren Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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