CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 20
- 主要终点
- Cryoablation Procedure Events (CPEs)
研究概览
简要总结
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.
详细描述
- To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
- To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
- To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.
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
- •Subjects must fulfill ALL of the following criteria:
- •Documented PAF:
- •diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
- •2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
- •18 and 75 years of age
- •Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.
排除标准
- •ANY of the following is regarded as a criterion for excluding a subject from the study:
- •Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- •Any previous LA surgery
- •Current intracardiac thrombus (can be treated after thrombus is resolved)
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Anteroposterior LA diameter > 5.5 cm by TTE
- •Presence of any cardiac valve prosthesis
- •Clinically significant mitral valve regurgitation or stenosis
- •Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
- •Unstable angina
- •Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
- •Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- •NYHA class III or IV congestive heart failure
- •Left ventricular ejection fraction (LVEF) < 40%
- •2º (Type II) or 3º atrioventricular block
- •Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- •Brugada syndrome
- •Long QT syndrome
- •Arrhythmogenic right ventricular dysplasia
- •Sarcoidosis
- •Hypertrophic cardiomyopathy
- •Known cryoglobulinemia
- •Uncontrolled hyperthyroidism
- •Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
- •Any woman known to be pregnant
- •Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:
- •negative β-HCG test within 7 days prior to Start Date
- •history of surgical sterilization
- •postmenopausal and free of menses for at least 12 months.
- •Life expectancy less than one (1) year
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study
- •Unwilling or unable to comply fully with study procedures and follow-up
结局指标
主要结局
Cryoablation Procedure Events (CPEs)
时间窗: 365 days
Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Freedom From Major Atrial Fibrillation Events (MAFE)
时间窗: 365 days
Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.
Long-term Clinical Success
时间窗: 180 days
Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Acute Procedural Success (APS)
时间窗: At the conclusion of the cryoablation procedure
Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
次要结局
未报告次要终点