Recruiting

NCT Number: NCT05884359

Left Bundle Branch Area Mapping for Conduction System Pacing

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.

Recruiting

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Key information

Conditions

Left Bundle-Branch Block Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pacemaker Ddd Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location status: Recruiting

Location contact

Michael Orlov, MD, PhD

CONTACT

[email protected]

617-789-3187

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Electroanatomical Mapping (NavX)

Diagnostic Test

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.

Other names: Implantation of a standard Left Bundle Area pacing lead and pacing device

Primary outcomes

Electroanatomical characteristics of the target area for Left Bundle lead implantation

Time frame: Through study completion, an average of 1 year

Electroanatomical metrics

Study contacts

Contact information is provided by the study sponsor or research team.

Karina Demchuk, BS

CONTACT

[email protected]

413-219-5207

Michael Orlov, MD, PhD

CONTACT

[email protected]

617-789-3187

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Jun 1, 2023
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting