NCT05884359 Left Bundle Branch Area Mapping for Conduction System Pacing
| NCT ID | NCT05884359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Steward St. Elizabeth's Medical Center of Boston, Inc. |
| Condition | Left Bundle-Branch Block |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-06-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Michael Orlov, MD, PhD
PRINCIPAL INVESTIGATOR
Steward St. Elizabeth's Medical Center of Boston, Inc.
Frequently Asked Questions
Who can join the NCT05884359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 88 Years, studying Left Bundle-Branch Block. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05884359 currently recruiting?
Yes, NCT05884359 is actively recruiting participants. Contact the research team at Michael.Orlov@steward.org for enrollment information.
Where is the NCT05884359 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05884359 clinical trial?
NCT05884359 is sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc.. The principal investigator is Michael Orlov, MD, PhD at Steward St. Elizabeth's Medical Center of Boston, Inc.. The trial plans to enroll 30 participants.