NCT01056328已完成不适用
Irrigated Ablation System Evaluation for AF
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 60
- 主要终点
- Confirmation of Entrance Block in the Pulmonary Veins
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Signed Patient Informed Consent Form
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- •Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD
- •Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*
- •PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.
排除标准
- •Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Previous ablation for AF
- •History of any valvular cardiac surgical procedure
- •Coronary artery bypass grafting (CABG) procedure within the last six months
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- •Left atrial thrombus
- •History of a documented thromboembolic event within the past one (1) year
- •Diagnosed atrial myxoma
- •An implanted implantable cardioverter defibrillator (ICD)
- •Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
- •Acute illness or active systemic infection or sepsis
- •Unstable angina
- •Myocardial infarction within the previous two months
- •Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure transthoracic echocardiogram (TTE)
- •History of blood clotting or bleeding abnormalities
- •Contraindication to anticoagulation (i.e. heparin or warfarin)
- •Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
- •Life expectancy less than 12 months
- •Enrollment in an investigational study evaluating another device or drug
- •Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
- •An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
- •Presence of a condition that precludes vascular access
- •Left atrial size ≥ 50 mm as determined by pre-procedure TTE
研究组 & 干预措施
St. Jude Medical Cardiac Ablation System
Experimental
干预措施: SJM Irrigated Cardiac Ablation System (Device)
FDA approved Open Irrigated Radio Frequency Ablation System
Active Comparator
干预措施: FDA approved Open Irrigated RF Ablation System (Device)
结局指标
主要结局
Confirmation of Entrance Block in the Pulmonary Veins
时间窗: 20 minutes after initial isolation
Incidence of Adverse Events Included in the Pre-specified Composite
时间窗: 7 days
Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
Incidence of Adverse Events Included in the Pre-specified Composite.
时间窗: 12 months
次要结局
- Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period(12 months)
- Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs(12 months)
研究者
研究点 (60)
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