NCT01677052已完成不适用
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 426
- 主要终点
- Acute Success
研究概览
简要总结
The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subjects with symptomatic atrial fibrillation (AF) who, in the opinion of the investigator, are candidates for ablation for atrial fibrillation. Candidates who have had previous ablation procedures may be included in the registry
- •Subjects who have failed at least one antiarrhythmic drug (AAD)(class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic atrial fibrillation, or intolerable to the AAD.
- •Subjects must be 18 years of age or older
- •Subjects must be able and willing to comply with all pre-, post and follow-up testing and requirements
- •Subjects must provide written informed consent to participate in the registry
排除标准
- •Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this registry
- •History of blood clotting or bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- •History of a documented thromboembolic event within the past year
- •Significant pulmonary disease (eg, 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
- •Previous cardiac surgery (eg, CABG) or valvular cardiac surgical procedure (eg, ventriculotomy, atriotomy, valve repair or replacement, presence of a prosthetic valve)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months)
- •Diagnosed atrial myxoma
- •Unstable angina
- •Uncontrolled heart failure Uncontrolled heart Failure or NYHA Class III or IV heart failure
- •Acute illness, active systemic infection, or sepsis
- •Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
结局指标
主要结局
Acute Success
时间窗: 1 year
Confirmation of entrance block in the pulmonary veins (acute success)
Contact Force
时间窗: 1 year
Contact force during ablation procedures
Adverse Events
时间窗: 1 year
Procedural complications and adverse events throughout the registry
次要结局
未报告次要终点
研究者
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