Comparison of Wide Area Circumferential Ablation With Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to first documented recurrence of atrial arrhythmias
研究概览
简要总结
The purpose of this randomized clinical trial is to compare the efficacy and safety of wide area circumferential ablation using contact force catheter with cryoballoon ablation for the treatment of paroxysmal atrial fibrillation.
详细描述
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with stroke, reductions in quality of life and overall survival. Previous studies have shown that cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation. However, the pulmonary vein isolation for radiofrequency catheter ablation in previous studies was done around each pulmonary-vein antrum, and it's not wide area circumferential ablation. Moreover, the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing was not performed in most of previous studies. We hypothesize that wide area circumferential ablation with contact force catheter and combined catheter ablation the potential atrial triggers and/or other atrial arrhythmias induced by aggressive induction is more effective than cryoballoon ablation in patients with paroxysmal atrial fibrillation.
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
- •Symptomatic PAF with at least two episodes and at least one episode documented (30 seconds episode length, documented by ECG within last 12 months).
- •Documented treatment failure for effectiveness of at least one anti-arrhythmic drug(AAD Type I or III, including β-blocker and AAD intolerance).
- •≥ 18 and ≤ 75 years of age.
- •Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
- •Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial.
排除标准
- •Exclusion criteria related to a cardiac condition
- •Patients with prosthetic valves.
- •Any previous LA ablation or surgery.
- •Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment.
- •Unstable angina pectoris.
- •Myocardial infarction within three months prior to enrollment.
- •Symptomatic carotid stenosis.
- •Chronic obstructive pulmonary disease with detected pulmonary hypertension.
- •Any condition contraindicating chronic anticoagulation.
- •Stroke or transient ischemic attack within six months prior to enrollment.
- •Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
- •New York Heart Association (NYHA) class III or IV congestive heart failure.
- •EF < 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history).
- •Anteroposterior LA diameter > 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment).
- •LA thrombus (TEE diagnostic performed on admission). Intracardiac thrombus.
- •PV diameter > 26 mm in right sided PVs.
- •Mitral prosthesis.
- •Hypertrophic cardiomyopathy
- •2° (Type II) or 3° atrioventricular block.
- •Brugada syndrome or long QT syndrome.
- •Arrhythmogenic right ventricular dysplasia.
- •Sarcoidosis.
- •Exclusion criteria based on laboratory abnormalities
- •Thrombocytosis (platelet count > 600,000 / µl), thrombocytopenia (platelet count < 100,000 / µl).
- •Any untreated or uncontrolled hyperthyroidism or hypothyroidism.
- •Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min).
研究组 & 干预措施
Wide area circumferential ablation
Device:Smart Touch® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
干预措施: Wide area circumferential ablation (Procedure)
Cryoballoon ablation
Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
干预措施: Cryoballoon ablation (Procedure)
结局指标
主要结局
Time to first documented recurrence of atrial arrhythmias
时间窗: 12 months
a blanking period of three months will be maintained after the initial procedure
次要结局
- Arrhythmia-related death(12 months)
- time to recurrent atrial fibrillation (AF)(12 months)
- quality of life changes at 12 months compared to baseline(12 months)
- time to the first occurrence of each of the components of the primary outcome(12 months)
- all-cause death(12 months)
- time to first cardiovascular hospitalization(12 months)
- number of cardiovascular hospitalizations (over-night stays)(12 months)
- time to first symptomatic AF recurrence(12 months)
- total procedural duration(12 months)
- total time of fluoroscopy(12 months)
研究者
Yuehui Yin
Proffessor
The Second Affiliated Hospital of Chongqing Medical University