NCT04272762已完成不适用
A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation (The SHAM-PVI Study)
East Sussex Hospitals NHS Trust4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年1月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Atrial fibrillation burden using continuous monitoring
研究概览
简要总结
This is a double blinded randomised placebo-controlled trial comparing the effects of catheter ablation (Cryoablation) versus a placebo procedure on atrial fibrillation burden, symptoms and quality of life
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
- Quadruple (Participant, Care Provider, Investigator, 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 greater than or equal to 18 years
- •Symptomatic paroxysmal or persistent atrial fibrillation despite at least one antiarrhythmic drug (AAD Type I or III, β-blocker or AAD intolerance).
- •Referred for catheter ablation
排除标准
- •Long term persistent AF (continuous episode lasting more than 1)
- •Prior left atrium catheter or surgical atrial fibrillation ablation
- •Patients with other arrhythmias requiring ablative therapy
- •Left atrium (LA) ≥5.5 cm
- •Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.
- •Awaiting cardiac surgery or PCI
- •Myocardial infarction within three months prior to enrolment.
- •Stroke or transient ischemic attack (TIA) within three months prior to enrolment
- •Unstable angina
- •Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
- •Any condition contraindicating chronic anticoagulation
- •Any untreated or uncontrolled hyperthyroidism or hypothyroidism
- •Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min)
- •Patients with metallic prosthetic valves
- •Pregnant or breastfeeding women
- •Medical conditions limiting expected survival to <1 year
- •History of claustrophobia or panic attacks
- •Left ventricular ejection fraction (LVEF) less than 35%
研究组 & 干预措施
Placebo
Placebo Comparator
placebo procedure
干预措施: Placebo (Procedure)
Ablation
Active Comparator
pulmonary vein isolation
干预措施: Cryoablation (Procedure)
结局指标
主要结局
Atrial fibrillation burden using continuous monitoring
时间窗: 6 months
次要结局
- Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode(6 months)
- Comparison of unscheduled use of health care services(6 months)
- Time to asymptomatic atrial tachyarrhythmia stratified by length of episode(6 months)
- Change in health related quality of life in each group (36-Item Short Form Survey Instrument )(Baseline and 6 months)
- Comparison of medical treatment ( Antiarrhythmic drug use)(6 months)
- Number of procedure related complications / adverse events(6 months)
- Change in AF specific quality of life score between each group (AF-PROMS)(Baseline and 6 months)
- Time to symptomatic atrial tachyarrhythmia stratified by length of episode(6 months)
研究者
Rick Veasey
Principal Investigator
East Sussex Hospitals NHS Trust
研究点 (4)
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