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

NCT ID: NCT06745778

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-26

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Tachycardia (VT) Ventricular Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ICD or CRT-D patients who have received LBBP implantation

Patients' EGMs can be recorded by Holter DR220

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Shanghai Tongren Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Simon Cao, Ph.D

Role: CONTACT

862133230325

Facility Contacts

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Weijian Huang, MD

Role: primary

+86-577-55579591

Zhaohui Qiu, MD

Role: primary

+86-21-52039999

References

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Ponnusamy SS, Ramalingam V, Ganesan V, Syed T, Kumar M, Mariappan S, Murugan S, Basil W, Vijayaraman P. Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study. Heart Rhythm O2. 2022 Dec 16;3(6Part B):723-727. doi: 10.1016/j.hroo.2022.08.004. eCollection 2022 Dec.

Reference Type RESULT
PMID: 36589004 (View on PubMed)

Other Identifiers

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LBBP-ICD study

Identifier Type: -

Identifier Source: org_study_id

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