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临床试验/NCT01006876
NCT01006876已完成3 期

Role of Coumadin in Preventing Periprocedural Thrombo-Embolism as a Complication of Radio Frequency Catheter Ablation in High-risk Atrial Fibrillation Patients

Texas Cardiac Arrhythmia Research Foundation1 个研究点 分布在 1 个国家目标入组 1,584 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,584
试验地点
1
主要终点
Absence of thromboembolic events 48 hours post-ablation

研究概览

简要总结

This study aims to explore the risk of periprocedural thromboembolic events in continuous versus interrupted Coumadin therapy in a large, randomized high-risk patient population undergoing radio-frequency catheter ablation for atrial fibrillation.

详细描述

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice, affecting 2.3 million people in the United States (1). A major cause of stroke, AF substantially increases the risk of thromboembolism which necessitates oral anticoagulation therapy (OAT) for high-risk patients. Radiofrequency percutaneous catheter ablation (RFCA) is an effective strategy for the treatment of symptomatic drug-refractory atrial fibrillation. However, periprocedural cerebrovascular accident (CVA) due to thrombus or air embolism remains one of the most serious complications of AF ablation. In spite of precautions taken before, during, and after the ablation to minimize the risk of CVA, the reported event rate remains 0.5-2.8% (2).

The incidence of thromboembolic events is dependent on the extensiveness of the ablation procedure as well as the periprocedural anticoagulation strategy (2). Some studies have described charring and soft thrombus formation when the temperature exceeds 100 degree C during RFCA, which probably is caused by blood protein denaturation and coagulation (3). Currently an open saline irrigation-tip ablation catheter (3.5 mm Thermocool catheter) is used which reduces the thermal injury by keeping the temperature under control (4), while enabling the operator to use high wattage RF energy to effectively ablate the arrhythmogenic focus.

The two most utilized periprocedural OAT strategies are; 1) discontinuation of Coumadin three to five days prior to ablation, utilization of heparin or enoxaparin before the procedures, and "bridging" low molecular weight heparin with Coumadin after ablation, and 2) RFCA with continuation of Coumadin before, during and after the procedure (2) without any change in dosage. Limited data are available regarding the risk of thromboembolism with and without periprocedural Coumadin in AF patients undergoing catheter ablation .The aim of this prospective randomized study is to evaluate the effect of the above two OAT strategies on the incidence of TE within 48 hours post-RFCA.

Patient Selection, Treatment and Follow-up Period:

Patients randomized as study group would continue Coumadin without any periprocedural change while undergoing catheter ablation. Those randomized as control group would discontinue Coumadin 3-4 days prior to ablation and replace it with heparin till the end of the procedure and bridge LMWH with Coumadin 48-72 hours after ablation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age- 18-75 years
  • Patients in paroxysmal, persistent or long-standing persistent (LSP) AF
  • patients with CHADS2 score ≥ 1
  • AF patients with INR in the range of 2.0-3.0 in the last 3-4 weeks prior to ablation

排除标准

  • Patients with known bleeding disorders or inherited thrombophilic disorder
  • Patients with oral contraceptives or estrogen replacement therapy
  • Patients with prosthetic heart valves
  • Patients unable or willing to give informed consent
  • Contraindications for Coumadin therapy
  • Patients with CHADS2 score zero
  • Contraindication to undergoing an MRI

研究组 & 干预措施

Study Arm

Active Comparator

Patients receive continuous Coumadin therapy throughout the study.

干预措施: Coumadin (Drug)

Control Arm

Active Comparator

Patients discontinue Coumadin 3-4 days prior to ablation and replace it with heparin until the end of the procedure and bridge low molecular weight heparin (LMWH) with Coumadin 48-72 hours after ablation.

干预措施: Coumadin (Drug)

结局指标

主要结局

Absence of thromboembolic events 48 hours post-ablation

时间窗: 48 hours

次要结局

  • Recurrence of AF and late thromboembolic events(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Natale

Medical director

Texas Cardiac Arrhythmia Research Foundation

研究点 (1)

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