Pulsed Field Ablation in the Coronary Sinus: Feasibility and Safety of a Novel Approach for Mitral Isthmus Block

Официальное название

Safety, Efficacy and Mid-term Outcomes of Pulsed Field Ablation for Mitral Isthmus Ablation Through Epicardial Approach

Обзор

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

Вмешательства

• Процедура Focal Pulsed Field Ablation of the Coronary Sinus
  This study utilizes focal pulsed-field ablation (PFA) specifically targeting the coronary sinus (CS) to achieve permanent electrical isolation of the mitral isthmus (MI). Unlike traditional radiofrequency ablation, this intervention delivers non-thermal, ultra-short high-voltage pulses that induce irreversible electroporation specifically in myocardial cells

Первичные конечные точки

• Acute Procedural Success of Mitral Isthmus Isolation [Срок оценки: Intraoperative (immediately following the ablation procedure)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07577544 · B2025-700

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗