Cryoballoon Ablation for Early Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 16
- 主要终点
- Single procedure success of cryoballoon ablation on patients with early persistent AF
研究概览
简要总结
The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year from first diagnosis of persistent AF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 documented symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. Persistent AF defined as:
- •Episode lasting longer than 7 days, but less than 1 year documented by consecutive ECG recordings of 100% AF greater than 7 days apart OR
- •Episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording
- •Date of first diagnosis of persistent AF within the last 12 months preceding the consent date
- •Age between 18 and 75 years
- •Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study
排除标准
- •Long-standing persistent AF (has lasted for ≥1 year)
- •Current diagnosis of paroxysmal AF
- •Anteroposterior LA diameter > 5.0 cm by TTE
- •Current intracardiac thrombus
- •Presence of one or more pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Primary pulmonary hypertension
- •NYHA class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measure by acceptable cardiac testing (e.g. TTE)
- •Hypertrophic cardiomyopathy
- •Previous LA ablation or surgery
- •Unstable angina
- •Presence of any cardiac valve prosthesis
- •Thrombocytosis, thrombocytopenia
- •Any condition contraindicating chronic anticoagulation
- •Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
- •Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
- •Cryoglobulinemia
- •Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
- •Uncontrolled hyperthyroidism
- •Any woman known to be pregnant or breastfeeding
- •Active systemic infection
- •Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators
- •Life expectancy ≤ 1 year
- •Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager
- •Exclusion criteria as per local laws (for France, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the French social security system)
研究组 & 干预措施
Cryoballoon ablation
Subjects will wear holter monitors at baseline, 6 months and 12 months
干预措施: Holter monitoring (Other)
结局指标
主要结局
Single procedure success of cryoballoon ablation on patients with early persistent AF
时间窗: 12 months
12 month success will be defined as absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias \>/= 30 seconds in duration from the end of the 90 day blanking period of the cryoballoon ablation procedure to at least 12 months after the cryoballoon ablation procedure. Only Arctic Front Advance catheters may be used to achieve the single procedure success and no additional empirical lesions and/or complex fractionated electrogram (CFE) ablations may be made. Additionally, subjects must not require any other intervention for AF following the index procedure. Right atrial flutter ablations and pharmacological and/or electrical cardioversion can be performed within the 90 day blanking period.
次要结局
- Use of class I and class III antiarrhythmic drugs(12 months)
- Changes in quality of life measurements between baseline, 6 months and 12 months after procedure(Baseline, 6 months, 12 months)
- Adverse events required to be collected during the study(12 months)
- Acute procedural success of cryoballoon ablation on patients with early persistent AF(Post-procedure)
- Success of cryoballoon ablation on patients with early persistent AF (allowing for multiple procedures)(12 months)
- Sinus rhythm restoration being followed by chronic prevention of AF recurrence(12 months)