FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
研究概览
简要总结
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).
详细描述
This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study subjects are required to meet all the following inclusion criteria to participate in this study:
- •Patients with documented drug resistant symptomatic PAF
- •Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
- •Patient participation requirements:
- •Lives locally.
- •Is willing and capable of providing Informed Consent to undergo study procedures.
- •Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
排除标准
- •Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- •AF that is:
- •Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- •Longstanding
- •Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
- •Any of the following cardiac procedures, implants or conditions:
- •Clinically significant arrhythmias other than AF, AFL or AT
- •Previous endocardial or epicardial ablation or surgery for AF
- •Hemodynamically significant valvular disease
- •Prosthetic heart valve
- •Heart Failure for example NYHA Class III or IV CHF, LVEF <40%, Heart failure hospitalization
- •Atrial or ventricular septal defect closure
- •Atrial myxoma
- •Left atrial thrombus
- •Left atrial appendage device or occlusion
- •Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
- •Significant or symptomatic hypotension
- •Bradycardia or chronotropic incompetence
- •History of pericarditis
- •History of rheumatic fever
- •History of congenital heart disease with any residual anatomic or conduction abnormality
- •Any pulmonary vein abnormality, stenosis or stenting
- •Any of the following cardiovascular procedures, implants, or conditions:
- •a. Within the 3 months preceding enrollment:
- •i. Myocardial infarction
- •ii. Unstable angina
- •iii. Percutaneous coronary intervention
- •iv. Treatment with amiodarone
- •b. Within the 6 months preceding enrollment:
- •i. Heart surgery
- •ii. Stroke or TIA
- •iii. Any thromboembolic event
- •iv. Carotid stenting or endarterectomy
- •v. Pericarditis or pericardial effusion
- •c. Within the 12 months following enrollment:
- •i. Any likelihood of cardiac surgery or transplant
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to, or unwillingness to use, systemic anticoagulation
- •Contraindications to both CT and MRI
- •Sensitivity to contrast media not controlled by premedication
- •Women of childbearing potential who are pregnant, lactating, not using birth control or planning to become pregnant during the anticipated study period
- •Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to
- •Body mass index (BMI) > 40
- •Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- •Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
- •Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- •Active malignancy or history of treated cancer within 24 months of enrollment
- •Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- •Clinically significant infection
- •Predicted life expectancy less than one year
- 另有 2 项未显示
结局指标
主要结局
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
时间窗: 12 months
Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.
Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events
时间窗: 7 days to12 Months
Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
次要结局
未报告次要终点