Left Bundle Branch Area Mapping for Conduction System Pacing

NCT05884359 | Recruiting FDA Device

• 1 other identifier: SEMC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker DDD; Left Bundle-Branch Block

Keywords

left bundle branch block; pacemaker; physiologic stimulation

Outcome Measures

Primary Outcomes (1)

• Electroanatomical characteristics of the target area for Left Bundle lead implantation

  Electroanatomical metrics

  Through study completion, an average of 1 year

Interventions

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.

Also known as: Implantation of a standard Left Bundle Area pacing lead and pacing device

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation for standard pacemaker indications at one location (Steward St. Elizabeth Medical Center).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

RECRUITING

Related Publications (3)

• Orlov MV, Jahangir A, McKelvey D, Armstrong J, Maslov M, Monin AJ, Koulouridis I, Casavant D, Wylie JV. His bundle pacing insights from electroanatomical mapping: Topography and pacing targets. J Cardiovasc Electrophysiol. 2020 Oct;31(10):2737-2743. doi: 10.1111/jce.14672. Epub 2020 Jul 23.

  PMID: 32666617 RESULT

• Orlov MV, Nikolaychuk M, Koulouridis I, Goldman A, Natan S, Armstrong J, Bhattacharya A, Hicks A, King M, Wylie J. Left bundle area pacing: Guiding implant depth by ring measurements. Heart Rhythm. 2023 Jan;20(1):55-60. doi: 10.1016/j.hrthm.2022.09.013. Epub 2022 Sep 21.

  PMID: 36152975 RESULT

• Orlov MV, Koulouridis I, Monin AJ, Casavant D, Maslov M, Erez A, Hicks A, Aoun J, Wylie JV. Direct Visualization of the His Bundle Pacing Lead Placement by 3-Dimensional Electroanatomic Mapping: Technique, Anatomy, and Practical Considerations. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006801. doi: 10.1161/CIRCEP.118.006801.

  PMID: 30739495 RESULT

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Orlov, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Orlov, MD, PhD

CONTACT

617-789-3187; Michael.Orlov@steward.org

Karina Demchuk, BS

CONTACT

413-219-5207; karina.demchuk@steward.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: June 1, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)