Pulsed Field Ablation in the Coronary Sinus: Feasibility and Safety of a Novel Approach for Mitra… (NCT07577544) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pulsed Field Ablation in the Coronary Sinus: Feasibility and Safety of a Novel Approach for Mitral Isthmus Block
30 participantsStarted 2026-05-15
Plain-language summary
Why This Study Is Important
* Many patients with atrial fibrillation (AF) continue to experience abnormal heart rhythms even after receiving standard treatments.
* Standard heat-based energy can be difficult to use in these areas because fast blood flow cools the tissue, and excessive heat may damage nearby structures like the right coronary artery.
Our Approach
* Investigators are testing a newer technology called pulsed field ablation (PFA).
* Unlike traditional methods, PFA uses ultra-short electrical pulses rather than heat to target heart cells specifically while protecting neighboring nerves and blood vessels.
* This study focuses on applying this energy within the coronary sinus to help achieve a more complete and lasting electrical block for the mitral isthmus.
What To Expect
* This study involves 30 participants who are already undergoing a catheter ablation procedure for atrial fibrillation.
* The research team will monitor how successful the procedure is at immediately stopping the abnormal electrical signals.
* Participants will have follow-up visits over six months to check for any returning heart rhythm issues and will receive a specialized heart scan (CTA) to ensure the nearby coronary arteries remain healthy
Who can participate
Age range
18 Years – 75 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:
* Symptomatic Atrial Fibrillation: participants must have a diagnosis of symptomatic paroxysmal or persistent atrial fibrillation.
* Documentation: The arrhythmia must be documented by electrocardiogram or Holter monitoring.
* Age Range: participants must be between 18 and 75 years of age.
* Study Compliance: participants must be willing and able to comply with the post-procedural follow-up schedule.
* Procedural Requirement: All patients must be candidates for linear ablation at the mitral isthmus (MI) and coronary sinus (CS) for substrate modification.
Exclusion Criteria:
* Prior Cardiac Procedures: Patients with a history of prior heart surgery or Left Atrial Appendage Occlusion (LAAO) are excluded.
* Heart Failure Severity: Individuals classified with New York Heart Association (NYHA) functional class III or IV are ineligible.
* Renal Impairment: Patients with advanced renal failure, defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m², are excluded.
* Intracardiac Thrombus: Any patient with a left atrial thrombus identified via transesophageal echocardiography (TEE) is excluded.
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
1
Acute Procedural Success of Mitral Isthmus Isolation
Timeframe: Intraoperative (immediately following the ablation procedure)