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
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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RECRUITING
50 participants
OBSERVATIONAL
2025-02-26
2026-06-30
Brief Summary
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• 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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
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 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 are pregnant
* Patients participate in another study that will confound this study
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Shanghai Tongren Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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LBBP-ICD study
Identifier Type: -
Identifier Source: org_study_id
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