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临床试验/NCT03520868
NCT03520868已完成不适用

Heparin Requirements in Patients Undergoing Atrial Fibrillation Ablation on Coumadin vs NOACs

Steward St. Elizabeth's Medical Center of Boston, Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Intra-procedural Heparin Requirements in patients taking NOACs and Coumadin

研究概览

简要总结

To observe, using a prospectively designed study, the effect of type of oral anticoagulant on intra-procedural heparin requirements in patients undergoing Atrial Fibrillation ablation and to assess whether ACT assay accurately reflects heparin anti coagulation effect.

详细描述

Atrial fibrillation (AF) is the most common arrhythmia affecting the US population and accounts for 15% of strokes worldwide. Radiofrequency ablation has become a frequently used therapy for treatment of afib after failure of at least one anti-arrhythmic drug. Pulmonary Vein Isolation (PVI) remains the cornerstone of AF ablation and requires transseptal puncture and placement of catheters in the left atrium which can be thrombogenic and cause stroke. This is avoided by intra-procedural infusion of heparin and the anti-coagulation effect is monitored using Activated Clotting Time (ACT). With the approval of Novel Oral Anti-Coagulants (NOAC), increasing number of patients are undergoing AF ablation on these medications. It has been observed that patients on NOACs require much larger doses of heparin and take longer time to reach therapeutic ACT. Consequently, patients are at higher risk for thromboembolism and stroke. On the other hand, higher doses of heparin can expose patients to excessive bleeding complications. The investigators seek to explain the mechanism of "heparin resistance" in such a patient population and to develop a protocol that can achieve therapeutic anticoagulation quicker.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • All adults, male and female, aged 18 and above.
  • Patients with paroxysmal, persistent or chronic AF
  • All patients must be on therapeutic doses of Coumadin or one of the NOACs for at least 1 month prior to the procedure.

排除标准

  • Patients with known primary or secondary coagulopathy (such as Hemophilia, vWF deficiency, active malignancy, ATIII deficiency, Factor V Leiden deficiency, Hx of recurrent DVT/PE)
  • Patients with hypoalbuminemia, cirrhosis
  • chronic LMWH therapy,
  • ESRD on HD, and severely impaired kidney function with CKD stage IV
  • prosthetic heart valves and
  • advanced liver disease
  • previous procedural complications such as tamponade

结局指标

主要结局

Intra-procedural Heparin Requirements in patients taking NOACs and Coumadin

时间窗: During the procedure

The investigators will measure the amount of intravenous heparin administered to each patient during the afib ablation to achieve therapeutic anticoagulation.

次要结局

  • Activated Clotting Time (ACT) measured to assess Heparin activity during Atrial Fibrillation Ablation(During the procedure)
  • Anti Factor Xa assay measured to assess Heparin activity during Atrial Fibrillation Ablation(During the procedure)

研究者

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

Michael Orlov

Electrophysiologist

Steward St. Elizabeth's Medical Center of Boston, Inc.

研究点 (1)

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