The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 20
- 主要终点
- Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
研究概览
简要总结
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
详细描述
The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure.
The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 ~ 36 months of follow-up post-pulsed field ablation procedure.
The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34~36 months of follow-up post-pulsed field ablation procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- •Two (2) or more episodes of recurrent PAF during the 6 months preceding the consent Date, AND
- •At least 1 episode of Atrial Fibrillation (AF) documented with a tracing within 12 months preceding the consent date.
- •Age 18 years or older
- •Therapeutic Failure for the treatment of Atrial Fibrillation (effectiveness or intolerance) of at least one active antiarrhythmic drug (AAD) for rhythm control.
- •Willing and Capable of providing Informed Consent to undergo study procedures AND
- •Participate in all examinations and follow-up visits and tests associated with this clinical study
排除标准
- •Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- •Any previous LA surgery
- •Current intracardiac thrombus (can be treated after thrombus is resolved)
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Body Mass Index (BMI) >45.0
- •Anteroposterior Left Atrial diameter > 5.5 cm by transthoracic echocardiography (TTE)/ intracardiac imaging (ICE)
- •Presence of any cardiac valve prosthesis
- •Clinically significant mitral valve regurgitation or stenosis
- •Myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angiography (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
- •Unstable angina
- •Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
- •Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- •New York Heart Association (NYHA) class III or IV congestive heart failure
- •Left ventricular ejection fraction (LVEF) < 35%
- •2º (Type II) or 3º atrioventricular block
- •Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- •Hypertrophic cardiomyopathy
- •Active Systemic infection
- •Uncontrolled hyperthyroidism
- •Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
- •Any woman known to be pregnant
- •Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- •Severe lung disease, pulmonary hypertension, or any lung disease associated with chronic abnormal blood gases or requiring supplemental oxygen
- •Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- •Active malignancy, or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
- •Life expectancy less than one (1) year
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study (data collection for registries or retrospective studies is permitted)
- •Unwilling or unable to comply fully with study procedures and follow-up
- •Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements
- •Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus, untreated sleep apnea or active alcohol abuse
结局指标
主要结局
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
时间窗: 12 Months
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure
Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months
时间窗: 12 Months
To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)
次要结局
- Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE(12 Months)
- Additional Performance Analyses: Acute Procedural Success(1 day)