RecruitingNCT05884359

Left Bundle Branch Area Mapping for Conduction System Pacing


Sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

Enrollment

30 participants

Start Date

Jun 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 88 Years

Inclusion Criteria1

  • consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.

Exclusion Criteria4

  • Recent MI-less than 3 months
  • 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

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Interventions

DIAGNOSTIC_TEST3D 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.


Locations(1)

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

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NCT05884359


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