Pulsed Field Ablation for the Treatment of Persistent Atrial Fibrillation: Pulmonary Vein Plus Superior Vena Cava Isolation Versus Pulmonary Vein Isolation Alone-A Prospective, Multicenter, Randomized Controlled Study
his study is for people aged 18 to 75 who have persistent atrial fibrillation (AFib) that has lasted less than one year and who are having their first catheter ablation procedure.
Atrial fibrillation is a common heart rhythm problem. A standard treatment is a catheter procedure called pulmonary vein isolation (PVI), which uses energy to disconnect the pulmonary veins from the rest of the heart. However, in persistent AFib, the heart rhythm often returns after PVI alone.
Some people also have abnormal electrical signals coming from a large vein above the right atrium called the superior vena cava (SVC). This study tests whether adding SVC isolation (SVCI) to the standard PVI procedure works better than PVI alone.
The study will use pulsed field ablation (PFA), a newer non-heating technology that targets heart muscle cells and may cause less damage to nearby structures such as the food pipe and nerves.
About 340 participants will be enrolled from around 10 hospitals in China. Using a computer process, half will be assigned to PVI alone and half to PVI plus SVC isolation. Neither the doctor nor the participant will be blinded to the group assignment because the difference between the two procedures is visible.
All participants will be followed for 12 months after the procedure. The main question is: after a 3-month healing period, how many people stay free from AFib and other atrial rhythm problems for the remaining 9 months without needing more ablation or new rhythm medicines? The study also looks at safety, quality of life, hospital stays, and whether the heart rhythm returns.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Tianyou Ling
- Номер телефона: +8618930235117
- Электронная почта: lty11498@rjh.com.cn
Места учебы
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Китай
- Ruijin Hostpial Shanghai Jiaotong University School of Medicine
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Persistent atrial fibrillation (AFib) duration < 1 year;
- Age 18-75 years;
- Willing to participate in this study, capable of understanding, and has signed the informed consent form; able to complete postoperative follow-up according to the protocol.
Exclusion Criteria:
- Significant cardiac dysfunction or structural abnormality: LVEF < 50% or left atrial anteroposterior diameter > 46 mm;
- Previous left atrial ablation or cardiac surgery (including left atrial appendage closure);
- Presence of permanent pacemaker, CRT, implantable cardiac monitor, or any type of ICD;
- Previous pulmonary vein stent, pulmonary vein stenosis, or superior vena cava stenosis;
- Previous unilateral phrenic nerve palsy;
- Any prosthetic heart valve or moderate-to-severe (grade 3-4) valvular regurgitation/stenosis;
- Any cardiac surgery, myocardial infarction, PCI/PTCA, or coronary stent implantation within 3 months prior to signing informed consent;
- Unstable angina, NYHA class III/IV heart failure, primary pulmonary hypertension, rheumatic heart disease, or hypertrophic cardiomyopathy;
- Thrombocytosis/thrombocytopenia, any disease contraindicating long-term anticoagulation, active systemic infection;
- Atrial fibrillation due to reversible causes (e.g., hyperthyroidism);
- Stroke or TIA within 6 months prior to signing informed consent;
- Pregnant or lactating women;
- Life expectancy < 1 year;
- Currently participating in or expected to participate in another drug/device/biologic clinical trial during the study period;
- Intracardiac thrombus, drug or alcohol addiction, unwillingness or inability to complete follow-up;
- Severe renal insufficiency (eGFR < 30);
- Previous catheter ablation for atrial fibrillation;
- Primary severe sick sinus syndrome.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation
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Pulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI).
Ablation is performed sequentially at each pulmonary vein and the pulmonary vein antrum, with the procedural endpoint of durable bidirectional electrical isolation.
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Экспериментальный: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus Superior Vena Cava Isolation
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Pulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI) followed by electrophysiological assessment for superior vena cava (SVC) triggers and additional superior vena cava isolation (SVCI) at the SVC-right atrium junction.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
Временное ограничение: 3 months after the ablation (after the blanking period) through the 12-month follow-up
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3 months after the ablation (after the blanking period) through the 12-month follow-up
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation
Временное ограничение: From the index ablation through 3 months after the index ablation
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From the index ablation through 3 months after the index ablation
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Time to first recurrence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL)
Временное ограничение: From the index ablation through 12 months after the index ablation
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From the index ablation through 12 months after the index ablation
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Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
Временное ограничение: From baseline through 12 months after the index ablation
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From baseline through 12 months after the index ablation
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Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on 12-Item Short Form Health Survey (SF-12) scores
Временное ограничение: From baseline through 12 months after the index ablation
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From baseline through 12 months after the index ablation
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Incidence of cardiovascular-related rehospitalization
Временное ограничение: From the index ablation through 12 months after the index ablation
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From the index ablation through 12 months after the index ablation
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Proportion of participants undergoing repeat catheter ablation
Временное ограничение: From the index ablation through 12 months after the index ablation
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From the index ablation through 12 months after the index ablation
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Composite of perioperative complications and serious adverse events (SAEs) within 30 days after the index ablation
Временное ограничение: From the index ablation through 30 days after the index ablation
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From the index ablation through 30 days after the index ablation
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PULSED-SVC Trial
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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