The Ottawa AF Cardioversion Protocol
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|ClinicalTrials.gov Identifier: NCT02192957|
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : April 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Lifepak 20E Defibrillator, Licence No: 61944||Not Applicable|
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.
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:
- the starting energy dose (200 J) and electrode placement (anterior-posterior)
- the second electrode placement (anterior-lateral) if the first shock is not successful
- addition of pressure to electrodes if second shock is not successful
- step up of energy dose (360 J) along with pressure to electrodes if third shock is not successful
- optional further steps at physician's choice if fourth shock is not successful
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||389 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Developing a Standardized Atrial Fibrillation Cardioversion Protocol|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||April 2018|
Ottawa AF Cardioversion
elective electrical cardioversion for atrial fibrillation (AF) using the Ottawa AF protocol
Device: Lifepak 20E Defibrillator, Licence No: 61944
Intervention will be carried out using Health Canada approved devices for electrical cardioversion, following the steps pre-specified in the Ottawa AF Protocol.
Ottawa AF Cardioversion
- Last shock efficacy [ Time Frame: immediately after cardioversion ]Last shock efficacy defined as success ( two or more beats of sinus rhythm) or failure.
- Adverse Events [ Time Frame: participants will be followed for the duration of hospital stay for elective cardioversion, an expected average of 2 hours. ]adverse events related to cardioversion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192957
|University of Ottawa Heart Institution|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||David H Birnie, MD||Ottawa Heart Institute Research Corporation|