NCT05884359Recruiting

Left Bundle Branch Area Mapping for Conduction System Pacing

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

Start Date

6/1/2023

Completion Date

12/1/2028

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.

Detailed Description

This is an observational study that will provide the data for further hypothesis generation and confirmation in a larger study. We will define and record electro-anatomical characteristics of the interventricular septum and surrounding areas. Several electro-anatomical characteristics will be measured during the lead placement into the Left Bundle Branch Area. Mapping will be performed with the pacing lead. We will collect electrocardiographic markers of successful and unsuccessful LBBA pacemaker implantation attempts and correlate them with electro-anatomical information.

Eligibility Criteria

Age Range: 18 years to 88 years

Inclusion Criteria: * 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation. Exclusion Criteria: * 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

Interventions

DIAGNOSTIC_TEST

3D Electroanatomical Mapping (NavX)

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Conditions

Left Bundle-Branch BlockPacemaker DDD

Locations

St. Elizabeth's Medical Center

Boston, Massachusetts 02135

United States