An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia

Обзор

This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.

Вмешательства

• Устройство Focal Pulse field Ablation
  Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.

Первичные конечные точки

• Acute procedural success [Срок оценки: immediately after the procedure]

Вторичные конечные точки (4)

• Chronic success [Срок оценки: 6 months after procedure]
• Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time [Срок оценки: immediately after the procedure]
• Incidence of device-related major adverse events (MAE) within 7 days after ablation [Срок оценки: within 7 days after ablation]
• Incidence of device-related severe adverse events (SAE) [Срок оценки: 3 months and 6 months after procedure]

Критерии участия

Критерии включения

• Subjects aged at least 18;
• Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
• 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

• Any prior cavo-tricuspid isthmus ablation;
• Unstable angina;
• Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
• Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
• At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
• Implantable devices such as ICDs, CRTS and pacemakers in the body;
• Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;
• Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;
• Previously received tricuspid metal valve replacement;
• Thromboembolic events (including transient ischemic attacks) within the past 6 months;
• Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;
• Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;
• Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;
• Acute systemic infection;
• Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;
• Women who are pregnant or breastfeeding or who cannot use contraception during the study period;
• Enrollment in another clinical trial evaluating other devices or drugs during the same period;
• Life expectancy less than 12 months (e.g. advanced malignancy);
• Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06157437 · fPFA001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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