RecruitingNot Applicable

Left Bundle Branch Area Mapping for Conduction System Pacing

United States30 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 88 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Electroanatomical characteristics of the target area for Left Bundle lead implantation

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT05884359

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Michael Orlov, MD, PhD

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

View on ClinicalTrials.gov More Left Bundle-Branch Block trials