Left Bundle Branch Area Mapping for Conduction System Pacing

Recruiting

• Conditions: Pacemaker DDD; Left Bundle-Branch Block

• Registration Number: NCT05884359
• Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-05-31
• Study Start: 2023-06-01
• Study First Posted: 2023-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electroanatomical characteristics of the target area for Left Bundle lead implantation	Through study completion, an average of 1 year	Electroanatomical metrics

Trial Locations

Locations (1)

St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States