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Active, not recruiting Observational

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
Phase
Observational
Started
2025-02-26
Last updated
2026-10-15

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
No
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)

FacilityCityRegionStatus
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
Shanghai Tongren Hospital Shanghai China
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