Pulsed-field Ablation Versus Sham Ablation to Treat Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- AF freedom
研究概览
简要总结
The study is planned as a single-blind, multicenter, prospective, randomized study. Sixty sbjects will be randomized 1:1 to either: (i) EP study + PFA, or (ii) EP study + Sham ablation control.
After informed consent is obtained, an implantable loop recorder (ILR) will be implanted within seven days, and an EP study will be scheduled for 30±5 days after ILR implantation.
Patients in both groups will first undergo an EP study to rule out a concealed AV bypass tract and supraventricular tachycardia (SVT). Patients will not be randomized if SVT or concealed AV bypass tract is found during the EP study. Once an SVT or bypass tract is excluded, randomization will be performed. Patients randomized to Ablation will undergo PVI using the commercially-available pentaspline PFA catheter (Farawave, Farapulse-BSCI Inc). Patients randomized to the Sham-ablation Control group will simply undergo approximately 20-30 min of anesthesia with propofol and benzodiazepines in a similar manner as patients in the ablation arm.
Primary endpoints will be assessed six months after the procedure.
ECGs will be monitored using implantable ECG monitors (ILR) in all patients. There will be two co-primary endpoints (assessed at six months or at cross-over if Early Exit):
- Freedom from recurrent AF/AT/AFL (post 2-month blanking), assessed as time-to first recurrence;
- Quality of life according to Atrial Fibrillation Effect on QualiTy of life (AFEQT) score at 6 months (or at cross-over if Early Exit).
详细描述
PURPOSE The purpose of PFA-Sham is to determine the relative efficacy of catheter ablation for symptomatic paroxysmal/persistent AF, when compared against a sham-ablation control procedure. This is a prospective, multi-center, single-blind, randomized trial.
There are two co-primary hypotheses. First, we hypothesize that patients in the catheter ablation group will experience greater freedom from recurrent AF/AT/AFL at 6 months post-procedure. There will be a two-month post-procedure blanking period in both groups. Freedom from AF/AT/AFL will be assessed as time to first recurrence (or to cross-over if earlier).
Second, compared with those in the sham-ablation control group, patients in the catheter ablation group will report higher quality of life as measured by the Atrial Fibrillation Effect on QualiTy of life (AFEQT) score, at 6 months post-procedure (or at cross-over if Early Exit).
METHODS The study will be a single-blind, multicenter, prospective, randomized control study. Subjects will be randomized 1:1 to either: (i) EP study + PFA, or (ii) EP study + Sham ablation control.
After informed consent is obtained, an implantable loop recorder (ILR) will be implanted within seven days, and an EP study will be scheduled for 30±5 days after ILR implantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years;
- •Paroxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF);
- •AFEQT score ≤ 50.
排除标准
- •Any prior AF ablation procedure (or left atrial ablation procedure)
- •Untreated other arrhythmias (e.g. atrial flutter, SVT, VT, frequent PVCs);
- •Long-standing Persistent AF episodes (any continuous episodes lasting > 1 year);
- •Permanent AF;
- •No ECG evidence of AF episode >30 seconds in the 6 months prior to randomization;
- •LA size > 55 mm;
- •Hypertrophic cardiomyopathy;
- •Valve disease (any aortic stenosis, moderate or severe mitral regurgitation);
- •Left ventricular ejection fraction ≤ 35% according to echocardiogram within 6 months of randomization;
- •Moderate or severe pulmonary hypertension;
- •History of tachycardia-induced cardiomyopathy;
- •Symptomatic coronary artery disease;
- •Presence of an artificial valve;
- •Life expectancy less than two years;
- •Known medical condition or contraindication causing potential complications for interventional procedures or follow up.
研究组 & 干预措施
Pulsed-field ablation arm
Patients will undergo catheter ablation using for atrial fibrillation using pulsed-field energy
干预措施: Pulsed-field ablation (Procedure)
Sham procedure arm
Patients will receive sham procedure (no ablation)
干预措施: Sham procedure (Procedure)
结局指标
主要结局
AF freedom
时间窗: 6 months
Freedom from recurrent AF/AT/AFL (post two month blanking period): assessed as time to first recurrence (or to cross-over)
Quality of life
时间窗: 6 months
Quality of life according to the Atrial Fibrillation Effect on QualiTy of life (AFEQT) score at six months post ablation (or at cross-over for Early Exits) AFEQT is a 20-item questionnaire that asks about the degree to which different AF-related symptoms, treatment effects, and satisfaction with treatment have affected the patient over the past 4 weeks. The range is from 0 to 100. Lower scores indicate higher AF severity.
次要结局
- 12-month Freedom from recurrent AF(12 months)
- 12-month differences in quality of life(12 months)
- Unplanned Cardiovascular Hospitalization(12 month)
- AF burden(6 months)
- Procedure-related Major Complications(2 months)
- Hospital Anxiety and Depression Score(6 months)
研究者
Pavel Osmancik
head of the dept. of cardiac arrhythmias
Charles University, Czech Republic