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

NCT06745778 · tracked via the Priya Life Science China tracker

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Phase

Observational

Started

2025-02-26

Last updated

2026-05-08

Condition(s) studied

Ventricular Tachycardia (VT)Ventricular Fibrillation

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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

Trial sites (2)

Facility	City	Region	Status
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	Recruiting
Shanghai Tongren Hospital	Shanghai	China	Recruiting

More Medtronic Cardiac Rhythm and Heart Failure trials in China

Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction Recruiting

Bolt CSP-M Holter Study Recruiting

The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG Active, not recruiting

Other trials for the same condition

Complex Arrhythmia Registry Recruiting

Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation Recruiting

Ventricular Tachycardia：A Registry Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06745778 on ClinicalTrials.gov ↗ ← All trials in China