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Trial record 70 of 245 for:    "ottawa heart institute"

The Ottawa AF Cardioversion Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02192957
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
David Birnie, Ottawa Heart Institute Research Corporation

Brief Summary:

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

Detailed Description:

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:

  • 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Other Names:
  • -HEARTSTART XL, Licence No: 24413.
  • -Kendall 1010P Multi-function Defibrillation Electrodes, Licence No: 21857




Primary Outcome Measures :
  1. Last shock efficacy [ Time Frame: immediately after cardioversion ]
    Last shock efficacy defined as success ( two or more beats of sinus rhythm) or failure.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of intracardiac thrombus
  • Pregnancy

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
University of Ottawa Heart Institution
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
David Birnie
Investigators
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Principal Investigator: David H Birnie, MD Ottawa Heart Institute Research Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Birnie, BSc (Hons), MB ChB, MRCP(UK), MD, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02192957     History of Changes
Other Study ID Numbers: 20140415
Form ID 2788 ( Other Identifier: Ottawa Health Science Network Research Ethics Board )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Keywords provided by David Birnie, Ottawa Heart Institute Research Corporation:
cardioversion
electrical cardioversion
atrial fibrillation
cardioversion protocol

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes