Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Freedom of atrial fibrillation after a 2-month blanking period up to 18 months post procedure.
研究概览
简要总结
Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.
详细描述
Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations. Patients will undergo the standard catheter ablation procedure in accordance with good clinical practice, performing pulmonary vein islolation (PVI) with the FARAPULSE cardiac ablation system. In the control group PVI will be performed with 4 basket- and 4 flower-shaped applications of the catheter, while in the study group 2 olive-, 4 basket-, and 6 flower shaped applications will be delivered at each vein. All other procedural steps will be the same between groups. Patients will be randomized in a 1:1 fashion with a block size of 4 to the study arm or the usual care (control) arm. The primary study parameter for efficacy is the freedom of atrial arrhythmias after the 2-month blanking period up to 18 months after the procedure. The secondary study outcomes include the extent and position of pulmonary vein reconnection observed during redo procedures that are performed due to arrhythmia recurrence, which constitutes a study endpoint. Furthermore, the study also evaluates arrhythmia burden after the procedure in centers that routinely use photoplethysmographic remote monitoring as standard care for all their ablation patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND
- •Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR
- •Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past
排除标准
- •Cerebrovascular accident (CVA) in the last 6 months
- •More than moderate valvular disease that would require intervention
- •Cardiac catheter/surgical intervention in the last 3 months or scheduled
- •Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
- •Left atrial appendage (LAA) closure in the past
- •Mechanical mitral valve
- •Non-adherence to oral anticoagulation in the 3 weeks prior to ablation
- •Renal disease with known eGFR<45 ml
- •Left atrial volume index (LAVI) >50 ml/m2 or left atrial diameter (LAD) >50 mm
- •Known contra-indication for catheter ablation
- •Known contra-indication for deep sedation or general anesthesia
- •Known pregnancy
研究组 & 干预措施
Control arm, standard of care
Pulmonary vein isolation will be performed with the pentaspline catheter in basket shape (4x) and flower shaped (4x) applications of the catheter.
干预措施: Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation (Device)
Experimental arm, extra applications
Pulmonary vein isolation will be performed with the pentaspline ablation catheter in an olive-shape (2x), basket shape (4x), and flower shape (6x) at each vein
干预措施: Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation (Device)
结局指标
主要结局
Freedom of atrial fibrillation after a 2-month blanking period up to 18 months post procedure.
时间窗: Baseline, month 3, month 6, month 12, month 18
The primary efficacy outcome will be the freedom of arrhythmias lasting \>30 seconds after a single PVI ablation procedure from the blanking period of 2 months until 18 months follow-up after ablation. Any left-sided ablation procedure after a successful index procedure will count as treatment failure. An atrioventricular (nodal) reentry tachycardia (AVNRT/AVRT), or typical right atrial flutter occurring after the index procedure, will not count as treatment failure.
Freedom of atrial fibrillation after a 2-month blanking period up to 12 months post procedure.
时间窗: Baseline, month 3, month 6, month 12.
The primary efficacy outcome will be the freedom of arrhythmias lasting \>30 seconds after a single PVI ablation procedure from the blanking period of 2 months until 12 months follow-up after ablation. The use of class I or III antiarrhythmic drugs should be stopped at the 3-month visit at the end of the blanking period, or else will count as treatment failure. Any left-sided ablation procedure after a successful index procedure will count as treatment failure. An atrioventricular (nodal) reentry tachycardia (AVNRT/AVRT), or typical right atrial flutter occurring after the index procedure, will not count as treatment failure.
次要结局
- Procedural-up-to-30 days and 30 days up-to 18 months safety of increasing PFA application numbers(From procedure to 18-month follow-up)
- Quality of life differences between groups(Baseline, month 3, month 6, month 12, month 18)
- The durability of pulmonary vein isolation in case of a redo procedure(Month 3, month 6, month 12, month 18.)
- Procedural-up-to-30 days and 30 days up-to 12 months safety of increasing PFA application numbers(From procedure to 12-month follow-up)
- Quality of life differences between groups(Baseline, month 3, month 6, month 12.)
- The potential for hemolysis in relation to application number(Post procedure every 24 hours, up to 5 days post procedure for each individual patient)
- The durability of pulmonary vein isolation in case of a redo procedure(Month 3, month 6, month 12.)
研究者
L.V.A. Boersma
Clinical professor
R&D Cardiologie