Cryoballoon Ablation Versus Medical Therapy in Patients With Atrial Fibrillation and Heart Failure With Different Ejection Fraction Categories
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Treatment success at one year
研究概览
简要总结
This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.
详细描述
Subjects with atrial fibrillation and heart failure with different ejection fraction categories are devided to either an anti-arrhythmic drug or cryoballoon catheter ablation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
- •At least 18 years old and not older than 80 years old.
- •Able and willing to give informed consent.
排除标准
- •History of AF treatment with class I or III AAD, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
- •Previous left atrial ablation.
- •Previous cardiac surgery including prosthetic valves.
- •Permanent pacemaker or defibrillator implant.
- •Second degree type II or third degree AV-block or a pattern of left/right bundle branch block.
- •History of previous myocardial infarction or percutaneous intervention during the last 3 months.
- •Any history of previous transient ischemic attack, prolonged reversible ischemic neurological deficit, and/or stroke.
- •Known intracardiac thrombus formation.
- •Pulmonary vein stent.
- •Known cryoglobulinaemia.
- •Active systemic infection.
- •Hypertrophic cardiomyopathy.
- •Life expectancy is ≤1 year.
- •Reversible cause of atrial fibrillation (eg, hyperthyroidism or alcoholism).
- •Abnormal long or short QT intervals, signs of Brugada syndrome, known family history of inherited ion channel disease, and/or arrhythmogenic right ventricular dysplasia.
- •Chronic obstructive pulmonary disease with detected pulmonary hypertension and/or any other evidence of significant lung disease.
- •Contraindication for oral anticoagulation.
- •Pregnant women or woman of childbearing potential with inadequate birth control.
- •Women who are breastfeeding.
- •Any significant congenital heart defect corrected or not corrected; however, patent foramen ovale is allowed.
- •Thrombocytosis (platelet count > 600,000/μL) or thrombocytopenia (platelet count < 100,000/μL).
- •Untreated or uncontrolled hyperthyroidism or hypothyroidism.
- •Renal dysfunction with glomerular filtration rate < 60 mL/min.
- •Unstable angina pectoris.
- •Symptomatic carotid stenosis.
- •Myxoma based on laboratory abnormalities.
- •Sarcoidosis.
- •Unwilling to unable to comply with the study procedure and follow-up schedule due to any disease condition.
- •Legal incapacity or evidence that the patient cannot understand the purpose and risks of the study, including inability to comply fully with study procedures and follow-up.
- •Employed by Medtronic, or the department of an investigator, or close-familial relative of an investigator.
- •Enrolled or planning to participate in a potentially confounding drug or device trial during this study.
研究组 & 干预措施
Medical treatment group
Using class I or class III AAD to maintain sinus rhythm
干预措施: Antiarrhythmic drug Therapy (Drug)
Cryoballoon ablation group
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
干预措施: cryoballoon ablation (Device)
结局指标
主要结局
Treatment success at one year
时间窗: one year
Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.
Rate of adverse events
时间窗: one year
Rate of complications and adverse events occurred during cryoballoon ablation and postoperative follow-up, including all-cause mortality, rehospitalisation for HF, and the composite event of all-cause mortality or HF hospitalisation
次要结局
- Quality of life changes at 12 months measured by 12-Item Short Form Survey (SF-12)(one year)
- Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)(one year)
- Arrhythmia recurrence during blanking period(3 months)