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临床试验/NCT02192957
NCT02192957已完成不适用

Developing a Standardized Atrial Fibrillation Cardioversion Protocol

David Birnie1 个研究点 分布在 1 个国家目标入组 389 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
389
试验地点
1
主要终点
Last shock efficacy

研究概览

简要总结

Atrial fibrillation is an abnormal heart rhythm in which the top chambers of the heart (the atrial chambers) beat very fast. Electrical cardioversion is a technique to convert heart rhythm from AF to normal rhythm. The technique sends out a brief electric shock to the heart through electrodes (paddles or skin patches) applied to the outside of the chest wall. The shock resets the heart rhythm back to its normal pattern.

This technique is practiced at many hospitals, including the Heart Institute, and is not experimental. However no detailed national or international guidelines exist to assist physicians in performing cardioversion. Physicians use a variety of methods. Electrical cardioversion does not always restore normal rhythm. Adjusting the electrical energy dose, changing the electrode position and applying pressure to the electrodes may improve the success rate.

This study will look at the safety and efficacy of a protocol (step by step method) for electrical cardioversion. The protocol prescribes the electrical energy dose, the electrode position and the application of pressure to the electrodes the physician will use. The individual elements of the protocol (energy dose, electrode position and pressure application) are often used by physician in clinical practice but not necessarily in the step by step order.

The purpose of this study is to get all doctors to follow a standard protocol 'the Ottawa AF cardioversion protocol'. We think that using this protocol will improve overall cardioversion success rates. The results of this study may change usual practice in Canada and in other countries.

All supplies, equipment and medications used in the protocol cardioversion are approved by Health Canada.

We estimate that 389 participants from the University of Ottawa Heart Institute will be enrolled in the study over the next 2 years. The results will be compared with a group of previous patients.

详细描述

Study design:

All eligible and consenting patients will undergo elective electrical cardioversion for atrial fibrillation (AF) using the Ottawa AF protocol.The fact that the physician follows the protocol makes this experimental. Aside from following the protocol, subjects will receive standard care before, during and after the procedure. Outcomes of the procedure and clinical features know to affect cardioversion efficacy will be collected. These will be compared to a group of 500 previous patients who underwent elective electrical cardioversion for AF at the Heart Institute.

Methodology:

The Ottawa AF protocol prescribes the electrical energy dose, the electrode position and the application of pressure to the electrodes the physician will use. The individual elements of the protocol (energy dose, electrode position and pressure application) are often used by physician in clinical practice but not necessarily in the step by step order.

The Ottawa AF protocol prescribes the following:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Documented atrial fibrillation within last 12 months
  • •On continuous systemic oral anticoagulation for 28 days prior to the day of cardioversion or must have undergone a recent (< 48 hrs) trans-esophageal echocardiogram prior to the day of cardioversion
  • •Able to provide informed consent

排除标准

  • •Presence of intracardiac thrombus
  • •Pregnancy

研究组 & 干预措施

Ottawa AF Cardioversion

Other

elective electrical cardioversion for atrial fibrillation (AF) using the Ottawa AF protocol

干预措施: Lifepak 20E Defibrillator, Licence No: 61944 (Device)

结局指标

主要结局

Last shock efficacy

时间窗: immediately after cardioversion

Last shock efficacy defined as success ( two or more beats of sinus rhythm) or failure.

次要结局

未报告次要终点

研究者

发起方
David Birnie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Birnie

BSc (Hons), MB ChB, MRCP(UK), MD

Ottawa Heart Institute Research Corporation

研究点 (1)

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