Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)

Официальное название

Pulsed Field Ablation of Superior Vena Cava in Addition to Pulmonary Vein in Paroxysmal Atrial Fibrillation: A Multicenter Randomized Controlled Trial (PASPA Study)

Обзор

The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF). 650 participants will be followed for 12 months. The main goal is to see if adding SVCI reduces arrhythmia recurrence without increasing complications such as phrenic nerve injury or sinus node dysfunction.

Подробное описание

The PASPA study addresses the limitations of traditional pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF), where recurrence rates remain significant due to non-pulmonary vein triggers such as the superior vena cava (SVC). Traditional ablation near the SVC carries risks of phrenic nerve and sinus node injury, and acute isolation success rates are only 75%-85%. Pulsed Field Ablation (PFA) selectively ablates cardiomyocytes through irreversible electroporation while sparing adjacent nerves and vessels, allowing safer SVC isolation. This prospective, multicenter, randomized controlled trial will enroll 650 patients with documented PAF, randomly assigned to PVI alone or PVI plus SVC isolation (SVCI) using PFA. Participants will be followed for 12 months with 7-day Holter monitoring at 3, 6, and 12 months. The primary endpoint is freedom from atrial fibrillation, atrial flutter, or atrial tachycardia episodes ≥30 seconds at 12 months. Secondary endpoints include atrial fibrillation burden and procedure-related complications such as phrenic nerve injury, cardiac tamponade, and sinus node dysfunction. Preliminary animal and pilot human studies indicate that PFA achieves 100% acute SVC isolation with minimal complications. The study aims to determine whether adding SVCI to PVI improves efficacy in PAF without increasing procedural risks, providing evidence to guide standardized ablation strategies.

Вмешательства

• Процедура PFA - PV + SVCI
  Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins AND the superior vena cava.
• Процедура PFA - PVI only
  Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins only. No ablation is performed in the superior vena cava.

Первичные конечные точки

• Freedom from atrial arrhythmia recurrence at 12 Months [Срок оценки: 12 month]

Вторичные конечные точки (1)

• Atrial Fibrillation Burden [Срок оценки: 12 month]

Критерии участия

Критерии включения

• Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor
• Age between 18 and 80 years
• Willing and able to provide written informed consent

Критерии исключения

• Intracardiac thrombus (left atrium or left atrial appendage)
• Left atrial anterior-posterior diameter > 60 mm
• Absolute contraindication to anticoagulation therapy
• Stroke or myocardial infarction within 1 month prior to enrollment
• Uncontrolled hyperthyroidism
• Pregnancy or planning pregnancy
• Life expectancy less than 1 year
• Previous atrial fibrillation ablation procedure
• Known or suspected AF triggers primarily originating from the SVC (based on pre-procedure mapping, if available)
• Inability or unwillingness to participate in the study or comply with follow-up requirements

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No — Шанхай

Идентификаторы

NCT: NCT07191626 · PASPA-2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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