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临床试验/NCT03868150
NCT03868150招募中4 期

Assessment of Intra-Operative Atrial Fibrillation Inducibility As a Screening Tool to Prevent Post-Operative Atrial Fibrillation With Prophylaxis Amiodarone

Stanford University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
600
试验地点
1
主要终点
Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients

研究概览

简要总结

Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF

详细描述

In the operating room, as part of the open heart surgery, the surgeon will stimulate the superior right atrium section of the heart with a pacemaker for 30 seconds just prior to starting the heart and lung bypass machine. The stimulation is done to see how sensitive the heart is to developing atrial fibrillation. This test result will be documented. The procedure will only take 60 seconds out of the entire operation. It does not involve taking any samples of tissue or blood. Following this step, if the heart demonstrates atrial fibrillation for at least 30 seconds then the participant will then be randomized to either receive the prophylactic drug treatment using Amiodarone or to no prophylactic drug administration. The participant has a 50% chance of receiving the FDA approved study drug Amiodarone. The study arms consist of prophylactic drug administration with Amiodarone, No prophylactic drug administration, or no atrial fibrillation reaction after stimulation with the pacemaker. The remainder of the surgical procedure will not be affected, and will follow routine surgical practice.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or replacement, combined CABG with valve repair or replacement, or valve sparing aortic root repair
  • Normal sinus rhythm
  • No documented history of atrial fibrillation

排除标准

  • Prior surgical procedures involving heart surgery and cardiopulmonary bypass
  • Any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds
  • Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias
  • Patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or Maze procedure.

研究组 & 干预措施

Inducible Atrial Fibrillation

Active Comparator

Treatment with Amiodarone

干预措施: Amiodarone Injection (Drug)

Inducible Atrial Fibrillation

Active Comparator

Treatment with Amiodarone

干预措施: Intraoperative Rapid Atrial Pacing (Device)

Inducible Atrial Fibrillation - Standard Care

Other

No initial Amiodarone Treatment unless POAF seen on post operative care unit.

干预措施: Amiodarone Injection (Drug)

Inducible Atrial Fibrillation - Standard Care

Other

No initial Amiodarone Treatment unless POAF seen on post operative care unit.

干预措施: Intraoperative Rapid Atrial Pacing (Device)

Non-Inducible Atrial Fibrillation

Other

Amiodarone treatment if POAF seen on post-operative care unit

干预措施: Intraoperative Rapid Atrial Pacing (Device)

结局指标

主要结局

Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients

时间窗: 30 days

Identify predictors of developing atrial fibrillation in the hope of decreasing post-operative length of stay, the need for anticoagulation, decrease risk of stroke, DVT, and bleeding

次要结局

未报告次要终点

研究者

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

Anson M Lee

Assistant Professor

Stanford University

研究点 (1)

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