FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
不适用
已完成
NCT01490814
| 适应症 | Symptomatic Paroxysmal Atrial Fibrillation |
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| 分期 | 不适用 |
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| 申办方 | Medtronic Cardiac Ablation Solutions |
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| 状态 | 已完成 |
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| 受试者人数 | 769 人 |
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| 干预(药物) | Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins |
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| 开始日期 | 2011年12月 |
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| 完成日期 | 2016年1月 |
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| 结果公布日 | 2018年11月2日 |
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摘要
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
Number of Subjects With Recurrence of Atrial Arrhythmias or Prescription of Anti-arrhythmic Drug or Re-ablation After a Blanking Period of Three Months After the Initial Ablation Procedure
33 months · Participants
| Cryoballoon Ablation | 138 Participants |
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| Radiofrequency Ablation | 143 Participants |
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Number of Subjects With a Primary Safety Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest.
33 months · Participants
| Cryoballoon Ablation | 334 Participants |
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| Radiofrequency Ablation | 325 Participants |
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| Cryoballoon Ablation | 2 Participants |
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| Radiofrequency Ablation | 0 Participants |
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| Cryoballoon Ablation | 2 Participants |
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| Radiofrequency Ablation | 2 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。