The Ottawa AF Cardioversion Protocol

NCT02192957 | Completed

• 2 other identifiers: 20140415Form ID 2788
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

cardioversion; electrical cardioversion; atrial fibrillation; cardioversion protocol

Outcome Measures

Primary Outcomes (1)

• Last shock efficacy

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

  immediately after cardioversion

Other Outcomes (1)

• Adverse Events

  participants will be followed for the duration of hospital stay for elective cardioversion, an expected average of 2 hours.

Study Arms (1)

Ottawa AF Cardioversion

OTHER

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

Device: Lifepak 20E Defibrillator, Licence No: 61944

Interventions

Lifepak 20E Defibrillator, Licence No: 61944 DEVICE

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

Also known as: -HEARTSTART XL, Licence No: 24413., -Kendall 1010P Multi-function Defibrillation Electrodes, Licence No: 21857

Ottawa AF Cardioversion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of intracardiac thrombus
• Pregnancy

Sponsors & Collaborators

• David Birnie: lead

Study Sites (1)

University of Ottawa Heart Institution

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

• Ramirez FD, Sadek MM, Boileau I, Cleland M, Nery PB, Nair GM, Redpath CJ, Green MS, Davis DR, Charron K, Henne J, Zakutney T, Beanlands RSB, Hibbert B, Wells GA, Birnie DH. Evaluation of a novel cardioversion intervention for atrial fibrillation: the Ottawa AF cardioversion protocol. Europace. 2019 May 1;21(5):708-715. doi: 10.1093/europace/euy285.

  PMID: 30535367 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David H Birnie, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: BSc (Hons), MB ChB, MRCP(UK), MD

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 17, 2014
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

CA (1)