Left Bundle Branch Area Mapping for Conduction System Pacing
NCT ID: NCT05884359
Last Updated: 2025-12-17
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
30 participants
OBSERVATIONAL
2023-06-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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3D Electroanatomical Mapping (NavX)
To utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. Patients will undergo placement of standard Left Bundle Area pacing leads for routine indications, during the implantation procedure electro-anatomical map of the target area and neighboring tissues will be created. Map characteristics will be analyzed and used intra-operatively to assist with lead placement along with standard pacing metrics and standard X-ray criteria. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Recent Percutaneous Coronary Revascularization-less than 2 weeks
* Recent Open-Heart Procedures (CABG, Valvular procedures, etc.)-less than 1 month
* Patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker
18 Years
88 Years
ALL
No
Sponsors
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Steward St. Elizabeth's Medical Center of Boston, Inc.
OTHER
Responsible Party
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Principal Investigators
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Michael Orlov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Steward St. Elizabeth's Medical Center of Boston, Inc.
Locations
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St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Orlov MV, Jahangir A, McKelvey D, Armstrong J, Maslov M, Monin AJ, Koulouridis I, Casavant D, Wylie JV. His bundle pacing insights from electroanatomical mapping: Topography and pacing targets. J Cardiovasc Electrophysiol. 2020 Oct;31(10):2737-2743. doi: 10.1111/jce.14672. Epub 2020 Jul 23.
Orlov MV, Nikolaychuk M, Koulouridis I, Goldman A, Natan S, Armstrong J, Bhattacharya A, Hicks A, King M, Wylie J. Left bundle area pacing: Guiding implant depth by ring measurements. Heart Rhythm. 2023 Jan;20(1):55-60. doi: 10.1016/j.hrthm.2022.09.013. Epub 2022 Sep 21.
Orlov MV, Koulouridis I, Monin AJ, Casavant D, Maslov M, Erez A, Hicks A, Aoun J, Wylie JV. Direct Visualization of the His Bundle Pacing Lead Placement by 3-Dimensional Electroanatomic Mapping: Technique, Anatomy, and Practical Considerations. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006801. doi: 10.1161/CIRCEP.118.006801.
Other Identifiers
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SEMC
Identifier Type: -
Identifier Source: org_study_id