NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 45
- 主要终点
- Total Procedure Time
研究概览
简要总结
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
详细描述
This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
- •Age 18 years or older
- •Patients must be able and willing to provide written informed consent to participate in the study
排除标准
- •Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Previous ablation for atrial fibrillation
- •Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
- •Uncontrolled heart failure, or NYHA Class III or IV heart failure
- •Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
- •Contraindication to anticoagulation
- •Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
- •Awaiting cardiac transplantation
- •Heart disease in which corrective surgery is anticipated within 6 months
- •Enrollment in investigational drug, biologic or device study
- •Subjects unwilling to comply with protocol or follow-up requirements
- •Patients who are pregnant
结局指标
主要结局
Total Procedure Time
时间窗: Day 0 (procedure)
Acute Procedural Success
时间窗: Day 0 (procedure)
Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Total Fluoroscopy Time
时间窗: Day 0 (procedure)
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
次要结局
- Fluid Volume Delivered Via Ablation Catheter(Day 0 (procedure))
- Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score(Screening to 12 Month Visit)
- Total Radiofrequency (RF) Time(Day 0 (procedure))
- Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation(12 Month Visit)
- Number of Patients With Repeat Ablations(1 year)
- Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit(12 Month Visit)
- Mean Number of Radiofrequency (RF) Applications(Day 0 (procedure))
- Post-procedure AF Symptoms(12 Month Visit)
- Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation(12 Month Visit)