Efficacy of Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation (SD-Cryo-AF): A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Frequency of acute pulmonary vein isolation after first ablation.
研究概览
简要总结
This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).
详细描述
This is a prospective, randomized clinical study performed at one centre. The objective is to assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation in patients with atrial fibrillation (AF).
140 subjects with paroxysmal or persistent atrial fibrillation referred for their first AF ablation procedures will be enrolled.
Recruitment, ablation and follow-up will be performed at Dep of Cardiology in Uppsala University Hospital, Uppsala, Sweden.
Study duration is 2 years with 12--months enrolment period and 1 year follow-up per subject.
Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon ablation catheter. Patients will be randomized to a single cryoballoon application guided by a multipolar recording catheter or to a conventional technique with 2 cryoballoon applications. After cryoballoon ablation of all pulmonary veins, PV conduction block will be assessed by a separate circular mapping catheter. Acute procedural success is defined as complete electrical isolation of a pulmonary vein assessed by entrance and exit block, including 20 minutes waiting time. Complications and duration of the procedure will be assessed.
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
- 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
- •Patients with paroxysmal or persistent AF verified by ECG
- •Patients with symptoms corresponding to at least Europe Heart Rhythm Association (EHRA) score 2.
排除标准
- •Sinus rhythm cannot be maintained for at least one hour after an electrical cardioversion.
- •Congestive heart failure with New York Heart Association (NYHA) class 3 or more.
- •Left ventricular ejection fraction < 35% not secondary to AF with inadequate rate control, according to the judgement of the investigator.
- •Left atrial diameter ≥ 55 mm judged by transthoracic echocardiography.
- •Prior AF ablation procedure.
- •Longstanding persistent AF
- •AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as AF triggered by other uniform supraventricular tachycardia.
- •Contraindication to treatment with anticoagulants.
- •Significant valvular disease or planned cardiac intervention.
- •Hypertrophic cardiomyopathy.
- •Recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease
- •Implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device.
- •Dual chamber- and single chamber-pacemaker when the patient is pacemaker dependent on ventricular level
- •Patients with contraindications for transseptal catheterization or appropriate vascular access is precluded.
- •Renal failure requiring dialysis or abnormalities of liver function tests.
- •Participant in investigational clinical or device trial.
- •Unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.
- •Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.
结局指标
主要结局
Frequency of acute pulmonary vein isolation after first ablation.
时间窗: Acute during ablation procedure
Frequency of complete pulmonary vein isolation after first pass of ablation as per protocol
次要结局
- Adverse/Serious Adverse events(Evaluated after 12 months)
- Fluoroscopy exposure(During ablation procedure)
- Procedure time(During ablation procedure)
- Reduction of symptom severity score after ablation(Evaluated after 12 months)
- Freedom from atrial fibrillation(Evaluated after 12 months)
- Quality of Life after ablation(Evaluated after 12 months)
- Reduction of overall symptoms of atrial fibrillation after ablation(Evaluated after 12 months)
- Cost of ablation procedure(Evaluated after initial ablation (within 24 h after ablation))
- Hospitalisation after ablation(Evaluated after 12 months)
- Quality of life after ablation (measured as EQ5D score)(Evaluated after 12 months)
- Maximum troponin I (ng/L) levels after ablation as a predictor of clinical success(Evaluated after 12 months)
- Age (years) as a predictor of clinical success(Evaluated after 12 months)
- Nt-proBNP levels before ablation as a predictor of clinical success(Evaluated after 12 months)
- Left atrial diameter (mm) before ablation as a predictor of clinical success(Evaluated after 12 months)
- Atrial conduction time as a predictor of clinical success(Evaluated after 12 months)
- Sex as a predictor of clinical success(Evaluated after 12 months)
- CHADsVASc score as a predictor of clinical success(Evaluated after 12 months)
- BMI (kg/m2) as a predictor of clinical success(Evaluated after 12 months)
- Left atrial volume (ml/m2) before ablation as a predictor of clinical success(Evaluated after 12 months)
研究者
Carina Blomstrom Lundqvist
Professor
Uppsala University Hospital