Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Jorge Romero
- 入组人数
- 198
- 试验地点
- 36
- 主要终点
- The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).
详细描述
This is an investigator-initiated, prospective, randomized, multi-center, Investigational Device Exemption (IDE) study. Subjects undergoing first-time ablation for paroxysmal atrial fibrillation will be randomized to receive either pulmonary vein isolation (PVI) alone or PVI combined with posterior wall isolation (PWI) using pulsed field ablation (PFA) with the FARAWAVE PFA catheter.
Following the index procedure, all participants will enter a 3-month blanking period, during which they will be closely monitored. After this period, anti-arrhythmic drug (AAD) therapy will be discontinued for all patients. Throughout the entire study, patients will be monitored using an implantable loop recorder (ILR) to assess the primary outcome of efficacy.
The study includes a 12-month follow-up period, and the primary objective is to assess and compare the efficacy, defined as an improvement in freedom from all-atrial arrhythmias, and safety, defined as the occurrence of all procedure-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Age 21-90 years.
- •Symptomatic PAF whether failed AAD or not.
- •At least one symptomatic episode of PAF lasting <7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
- •Patients undergoing first time ablation for AF.
- •Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.
排除标准
- •Persistent atrial fibrillation (PeAF) (> 7 days in duration).
- •Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.
- •Previous surgical or catheter ablation of AF.
- •Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.
- •Left atrium anteroposterior (LA AP) diameter >55 mm or indexed left atrium (LA) volume >48 ml/m
- •Contraindications to oral or systemic anticoagulation.
- •Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.
- •Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
- •Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
- •History of PV stenosis.
- •History of severe pulmonary hypertension.
- •History of diaphragmatic paresis or hemi-paresis.
- •History of heart transplantation.
- •History of blood clotting or bleeding abnormalities.
- •Life expectancy of less than 12 months.
- •Presence of intracardiac thrombus.
- •Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries.
- •Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA.
- •Pacing dependent patients.
- •Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).
- •Active systemic infection.
- •Participation in any other AF-related randomized clinical trial.
研究组 & 干预措施
Pulmonary Vein Isolation (PVI) only
Pulsed field ablation of the pulmonary veins only.
干预措施: Farapulse PFA, Pulmonary Vein Isolation alone (Device)
Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)
Pulsed field ablation of the pulmonary veins and the posterior wall of the left atrium.
干预措施: Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation (Device)
结局指标
主要结局
The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure.
时间窗: 12 Months
All number of acute procedure-related complications will be reported and assessed including: atrio-esophageal fistula, cardiac perforation, pulmonary vein (PV) stenosis, acute kidney injury, phrenic nerve paralysis, thromboembolic events, stroke, or transient ischemic attacks (TIA), and other major adverse events within the 12 months following the ablation procedure: pericarditis cardiac tamponade pericardial effusion, coronary artery spasm, Vascular access complication/major bleeding, local hematoma, ecchymosis left atrium or vascular laceration
Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.
时间窗: 12 months
will be assessed by: * Occurrence of all atrial arrhythmias after the 3-month blanking period. * Any cardioversion for atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) after the 3-month blanking period. * Use of any type I or type III antiarrhythmic medication for the treatment of AF, AFL, or AT after the 3-month blanking period, or the use of amiodarone at any time. * Re-ablation of AF, AFL, or AT.
次要结局
- fluoroscopy time.(during 1-2 hours procedure.)
- Procedural time(12 Months)
- Procedure-related Recurrencies(12 Months)
- Pulsed field ablation (PFA) applications during procedure.(During 1-2 hours procedure.)
- Complications.(12 Months.)
- Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT).(12 Months)
- Freedom from atrial arrhythmias medication(12 Months)
- Use of amiodarone(12 months)
- first-pass pulmonary vein isolation (PVI).(During 1-2 hours procedure.)
研究者
Jorge Romero
Professor of Medicine
State University of New York - Upstate Medical University