NCT05884359

Left Bundle Branch Area Mapping for Conduction System Pacing

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Bundle-Branch Block
• Pacemaker DDD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-06-01
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study