STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 24
- 主要终点
- Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events.
研究概览
简要总结
To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the subjects be drug refractory.
详细描述
Subjects with paroxysmal atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of symptomatic paroxysmal AF with the following documentation: (1) physician's note indicating recurrent self- terminating AF or paroxysmal AF; and (2) any ECG documented AF within 6 months prior to enrollment.
- •Age 18-80
排除标准
- •History of AF treatment with class I or III antiarrhythmic drug, 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.
- •Prior persistent AF (cardioversion after 48 hours or continuous AF that is sustained >7 days)
- •Left atrial diameter greater than 5.0 cm
- •Prior left atrial ablation or left atrial surgical procedure
- •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)
- •Body mass index (BMI) >35 kg/m2
- •Presence of any pulmonary vein stents
- •Known presence of any pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Presence of any cardiac valve prosthesis
- •Moderate or severe mitral valve regurgitation or stenosis
- •Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/ percutaneous transluminal coronary angioplasty or coronary artery stenting which occurred during the 90 day interval preceding the date the subject signed the Informed Consent Form
- •Unstable angina
- •New York Heart Association (NYHA) class III or IV congestive heart failure and/or known left ventricular ejection fraction (LVEF) less than 45%
- •Diagnosis of primary pulmonary hypertension
- •Rheumatic heart disease
- •Thrombocytosis, thrombocytopenia
- •Contraindication to anticoagulation therapy
- •Active systemic infection
- •Hypertrophic cardiomyopathy
- •Cryoglobulinemia
- •Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, obstructive sleep apnea, and acute alcohol toxicity.
- •Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 180 day interval preceding the date the subject signed the Informed Consent Form, or any known unresolved complications from previous stroke/transient ischemic attack
- •Existing thrombus
- •Pregnancy
- •Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed.
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
- •Patients with contraindications to a Holter monitor
- •Unwilling or unable to comply fully with study procedures and follow-up
研究组 & 干预措施
Anti-arrhythmic drug
干预措施: Antiarrhythmic drug (Drug)
Cryoablation
干预措施: Cryoablation (Device)
结局指标
主要结局
Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events.
时间窗: Randomization to 12 months
Measured by rate of composite list of serious adverse events in cryoablation-treated as randomized arm. Includes: * TIA within 7 days * Cerebrovascular accident within 7 days * Major bleed that requires transfusion or results in a 20% or greater fall in hematocrit (HCT) within 7 days * Development of a significant pericardial effusion within 30 days. (One that results in hemodynamic compromise, requires elective or urgent pericardiocentesis, or results in a 1-cm or more pericardial effusion as documented by echocardiography). * Symptomatic PV stenosis within 12 months; accompanied by one of the following: 50%-75% reduction in diameter of the pulmonary vein, with symptoms not explained by other conditions; OR \>75% reduction in diameter of the pulmonary vein * MI within 7 days * PNI unresolved at 12 months * AE fistula within 12 months * Major vascular complication that requires intervention, prolongs hospital stay, or requires hospital admission (within 7 days).
Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter.
时间窗: Randomization to 12 months
Treatment success after AAD initiation (control arm) or pulmonary vein isolation ablation procedure utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter (treatment arm). Treatment success is the opposite of treatment failure. Treatment failure was defined as any of the following: * Acute procedural failure (treatment arm only). * Documented AF/AT/AFL on ambulatory monitoring/12-lead ECG after the 90-day post-ablation blanking period (treatment)/AAD optimization period (control arm). Minimum of 30 seconds on ambulatory monitoring or 10 seconds on 12-lead ECG. * Any subsequent AF surgery or ablation in the left atrium. * Any subsequent cardioversion after the 90-day post-ablation blanking period (treatment)/AAD optimization period (control arm). * Class I or III antiarrhythmic drug (or sotalol) use after the 90-day blanking period (treatment arm only).
次要结局
- Quality of Life Scores at Baseline Compared to 12 Months(Baseline and 12 Months)
- Healthcare Utilization(Initial treatment through 12 months.)