Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 81
- 主要终点
- Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter
研究概览
简要总结
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
详细描述
The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).
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
- •Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation.
- •At least two symptomatic AF episodes within last six months from enrollment.
- •At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.
- •Failed at least one Class I or Class III antiarrhythmic drug.
- •Age 18 -75 years.
排除标准
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Previous surgical or catheter ablation for AF.
- •Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days.
- •Any percutaneous coronary intervention within the past 2 months.
- •Valve repair or replacement or presence of a prosthetic valve.
- •Any carotid stenting or endarterectomy within the past 6 months.
- •Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
- •Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
- •LA antero posterior diameter > 50 mm.
- •Left Ventricular Ejection Fraction (LVEF) < 40%.
- •Contraindication to anticoagulation (e.g., heparin).
- •Myocardial infarction within the past 2 months.
- •Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
- •Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- •Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- •Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- •Life expectancy or other disease processes likely to limit survival to less than 12 months.
结局指标
主要结局
Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter
时间窗: Within 7 days post-procedure (Day of procedure = Day 0)
An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. PAEs included myocardial infarction, thromboembolism, transient ischemic attack, phrenic nerve paralysis, major vascular access complication/bleeding, pericarditis, pulmonary edema (respiratory insufficiency), stroke/cerebrovascular accident (CVA), hospitalization (initial or prolonged), device or procedure related death, atrio-esophageal fistula, pulmonary vein stenosis.
Number of Participants With Effectiveness Success
时间窗: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)
Effectiveness success was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram \[ECG\]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (example, entrainment or activation mapping) in an EP study.
次要结局
- Percentage of Participants With Acute Procedural Success(Day 0 (day of procedure))
- Percentage of Participants With Alternative 12-Month Success(From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0))
- Percentage of Participants With 12-Month Symptomatic Recurrence(From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0))
- Change From Baseline in Quality of Life as Assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Scale Score(Baseline, Month 12)
- Percentage of Participants With 12-Month Single Procedure Success(From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0))