RecruitingNCT06745778

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


Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Enrollment

50 participants

Start Date

Feb 26, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

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

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Locations(2)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Shanghai Tongren Hospital

Shanghai, China

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NCT06745778


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