Mapping the Left Bundle Branch Area for Pacemaker Placement
Left Bundle Branch Area Mapping for Conduction System Pacing
This study is testing how using 3D mapping technology during pacemaker placement can help doctors understand the heart's Left Bundle Branch Area better and improve the success of the procedure for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Sponsor | Steward St. Elizabeth's Medical Center of Boston, Inc. Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05884359 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize 3D mapping technology to investigate the electro-anatomical and electrocardiographic features of the Left Bundle Branch Area during pacemaker implantation. By prospectively reviewing data from 30 patients undergoing this procedure, the study seeks to enhance the understanding of the anatomical characteristics of this area, which may lead to improved implantation techniques. The study will measure various electro-anatomical markers during lead placement and correlate these with the success or failure of the pacemaker implantation.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 88 who are scheduled for Left Bundle Branch area pacemaker implantation.
Not a fit: Patients who are acutely ill, unstable, or have had recent heart procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and precise pacemaker placements, improving patient outcomes.
How similar studies have performed: While this approach is innovative, it builds on existing knowledge of electro-anatomical mapping, and similar studies have shown promise in improving pacing techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- St. Elizabeth's Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael Orlov, MD, PhD — Steward St. Elizabeth's Medical Center of Boston, Inc.
- Study coordinator: Michael Orlov, MD, PhD
- Email: Michael.Orlov@steward.org
- Phone: 617-789-3187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.