Recruiting

Conduction System Pacing

Sponsor:

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

Code:

NCT05884359

Conditions

Left Bundle-Branch Block

Pacemaker DDD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

3D Electroanatomical Mapping (NavX)

Study Details

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

Left Bundle-Branch Block

Pacemaker DDD

Study ID

NCT05884359

Start date

Jun 1, 2023

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Electroanatomical characteristics of the target area for Left Bundle lead implantation [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Michael Orlov, MD, PhD

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

Karina Demchuk, BS

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

Locations

St. Elizabeth's Medical Center

Recruiting

Boston, Massachusetts, United States, 02135

Contacts

Michael Orlov, MD, PhD

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

More Information

Sponsor

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

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • left bundle branch block
  • pacemaker
  • physiologic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Steward St. Elizabeth's Medical Center of Boston, Inc. on 2026-07-21.