Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation

Официальное название

Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial

Обзор

Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.

Вмешательства

• Устройство CardiPulse
  abc
• Устройство FaraPulse
  bcd

Первичные конечные точки

• 12-month atrial fibrillation (AF) ablation success rate [Срок оценки: 12 months post-procedure]

Вторичные конечные точки (10)

• Acute pulmonary vein ablation success rate [Срок оценки: Immediately post-procedure]
• Incidence of major adverse events (MAEs) related to the device [Срок оценки: Within 7 days post-procedure]
• Incidence of repeat ablation [Срок оценки: Within 12 months post-procedure]
• AF burden [Срок оценки: 6 and 12 months post-procedure]
• Incidence of cardiovascular MAEs [Срок оценки: Within 12 months post-procedure]
• Technical success rate of LAAC [Срок оценки: Immediately post-procedure]
• LAA closure rate [Срок оценки: 3 and 6 months post-procedure]
• Incidence of new residual shunt [Срок оценки: 3 and 6 months post-procedure]
• Incidence of device-related thrombus [Срок оценки: Within 12 months post-procedure.]
• Discontinuation rate of anticoagulants and antiarrhythmic medications [Срок оценки: Within 12 months post-procedure]

Критерии участия

Критерии включения

• Older than 18 years.
• Diagnosed with drug-refractory, symptomatic atrial fibrillation.
• The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
• Have a situation of:

• requires oral anticoagulation therapy
• high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy.
• Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Критерии исключения

• History of persistent atrial fibrillation >1 year.
• Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
• Left atrial anteroposterior diameter >50 mm.
• Evidence of left atrial or left atrial appendage thrombus on imaging examination.
• Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.
• Rheumatic heart disease.
• Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
• Unstable angina.
• Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
• History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
• Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
• Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
• Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
• Active systemic infection.
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
• Pregnancy or breastfeeding.
• Life expectancy <12 months (e.g., advanced malignancy).
• Current or anticipated participation in other drug or device clinical trials.
• Any other condition or abnormality deemed by the investigator to warrant exclusion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ningbo First Hospital — Ханчжоу

Идентификаторы

NCT: NCT07036965 · CP-IIS-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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