Actively Recruiting

Age: 18Years +
All Genders
ID06745778

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

Led by Medtronic Cardiac Rhythm and Heart Failure · Updated on 2026-05-08

50

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

2

Shanghai Tongren Hospital

Shanghai, China, 200025

Actively Recruiting

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Research Team

S

Simon Cao, Ph.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study.

Shunmuga Sundaram Ponnusamy, Vadivelu Ramalingam, Vithiya Ganesan...

https://pubmed.ncbi.nlm.nih.gov/36589004