NL-OMON34575已完成4 期
CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects with Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study - CLARITY study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF. AT least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
排除标准
- •1. Longstanding persistent atrial fibrillation
- •2. Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
- •3. Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
- •4. Previous ablation for AF
- •5. LA size > 55 mm
研究者
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