Left Bundle Branch Area Mapping for Conduction System Pacing
NCT05884359 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2025-12-17
Summary
This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.
Conditions
- Left Bundle-Branch Block
- Pacemaker DDD
Interventions
- DIAGNOSTIC_TEST
-
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.
Sponsors & Collaborators
-
Steward St. Elizabeth's Medical Center of Boston, Inc.
lead OTHER
Principal Investigators
-
Michael Orlov, MD, PhD · Steward St. Elizabeth's Medical Center of Boston, Inc.
Eligibility
- Min Age
- 18 Years
- Max Age
- 88 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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