A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 706
- 试验地点
- 34
- 主要终点
- Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs
研究概览
简要总结
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are required to meet all the following inclusion criteria to participate in this study:
- •Patients with drug-resistant symptomatic PAF meeting all the following criteria:
- •a. Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset.
- •b. Frequency: i. Physician documentation of recurrent PAF (two or more episodes) within 6 months, AND
- •ii. At least one (1) documented episode by a recording such as ECG, EM, Holter monitor or telemetry strip within 12 months of enrollment.
- •c. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.
- •Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
- •Patient who are willing and capable of:
- •Providing informed consent to undergo study procedures AND
- •Participating in all examinations and follow-up visits and tests associated with this clinical study.
排除标准
- •Patients will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- •AF that is any of the following:
- •Persistent (both early and longstanding) by diagnosis or continuous duration > 7 days
- •Requires four (4) or more direct-current cardioversions in the preceding 12 months
- •Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes
- •Any of the following atrial conditions:
- •Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
- •Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
- •Any prior atrial surgery
- •Intra-atrial septal patch or interatrial shunt
- •Atrial myxoma
- •Current LA thrombus
- •LA appendage closure, device or occlusion, past or anticipated
- •Any PV abnormality, stenosis or stenting (common and middle PVs are admissible)
- •At any time, one (1) or more of the following cardiovascular procedures, implants or conditions:
- •a. Sustained ventricular tachycardia or any ventricular fibrillation
- •b. Hemodynamically significant valvular disease:
- •i. Valvular disease that is symptomatic
- •ii. Valvular disease causing or exacerbating congestive heart failure
- •iii. Aortic stenosis: if already characterized, valve area < 1.5cm or gradient > 20 mm Hg
- •iv. Mitral stenosis: if already characterized, valve area < 1.5cm or gradient > 5 mm Hg
- •v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements
- •c. Hypertrophic cardiomyopathy
- •d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
- •e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
- •f. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access
- •g. History of rheumatic fever
- •h. History of congenital heart disease with any residual anatomic or conduction abnormality
- •Any of the following procedures, implants or conditions:
- •At baseline:
- •i. New York Heart Association (NYHA) Class III/IV
- •ii. Left ventricular ejection fraction (LVEF) < 40%
- •iii. Symptomatic hypotension
- •iv. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment)
- •v. Symptomatic resting bradycardia
- •vi. Implantable loop recorder or insertable cardiac monitor,
- •b. Within the 3 months preceding the Consent Date:
- •i. Myocardial infarction
- •ii. Unstable angina
- •iii. Percutaneous coronary intervention
- •iv. Heart failure hospitalization
- •v. Treatment with amiodarone
- •vi. Pericarditis or symptomatic pericardial effusion
- •vii. Gastrointestinal bleeding
- •c. Within the 6 months preceding the Consent Date:
- •i. Heart surgery
- •ii. Stroke, TIA or intracranial bleeding
- •iii. Any thromboembolic event
- •iv. Carotid stenting or endarterectomy
- •Diagnosed disorder of blood clotting or bleeding diathesis
- 另有 27 项未显示
研究组 & 干预措施
FARAPULSE Pulsed Field Ablation System
干预措施: FARAPULSE Pulsed Field Ablation System (Device)
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
干预措施: RadioFrequency and Cryoballoon Ablation (Device)
结局指标
主要结局
Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs
时间窗: 7 days and 12 Months
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs
Primary Effectiveness Endpoint
时间窗: 12-Months
Treatment Success: The primary effectiveness endpoint is Treatment Success in MITT Subjects, defined as: 1. Acute Procedural Success AND 2. Chronic Success, defined as freedom from: 1. At the Index / Rescheduled Index Procedure: Use of a non-randomized treatment modality for PVI 2. After the Blanking Period: i. Occurrence of any Detectable AF, AFL or AT (excluding CTI-dependent flutter confirmed by EP study) ii. Any cardioversion for AF, AFL or AT (excluding for CTI-dependent flutter) iii. Use of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL or AT c. At any time: i. Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter) ii. Use of amiodarone, except intra-procedurally to control an arrhythmia Endpoint status will be assessed through the Month 12 Assessment (Day 360 ± 30).
次要结局
- Change in PV Cross-sectional Area(3 months)
- Primary Effectiveness Treatment Success Tested for Superiority(12 Months)