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临床试验/NCT02569255
NCT02569255已完成不适用

Safe Use of New Oral Anticoagulants in Patients Treated by Catheter Ablation for Atrial Fibrillation

Private Hospital Heart Center Varde0 个研究点目标入组 234 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
234
主要终点
Number of participants with bleeding or thromboembolism during PVI and/or three months of follow up

研究概览

简要总结

Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All complications possible being related to the use of NOAC are registered.

详细描述

Use of new oral anticoagulants (NOAC) in patients before and after radiofrequency ablation with pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients paused their NOAC treatment for 24 hours before ablation. Patients were routinely followed up after 3 months with a standard formular focused on possible adverse events (major bleeding complications or thromboembolic events) to NOAC treatment. Adverse events related to the use of NOAC were registered during treatment or during 3 months of follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Symptomatic atrial fibrillation despite pharmacological treatment.

排除标准

  • 未提供

结局指标

主要结局

Number of participants with bleeding or thromboembolism during PVI and/or three months of follow up

时间窗: Up to three months after PVI

Any bleeding or thromboembolism observed during the PVI procedure and/or during 3 months of follow-up are registered. Also, if any procedure related complication was worsened by treatment with NOAC was registered.

次要结局

未报告次要终点

研究者

发起方
Private Hospital Heart Center Varde
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Steen Hansen

Chief Electrophysiologist, MD, Ph.D., DMSci

Private Hospital Heart Center Varde

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