Comparison of High Versus Escalating Shocks in Cardioverting Atrial Fibrillation

March 20, 2019 updated by: University of Aarhus

The Efficiency and Safety of a High Energy Shock Protocol (360-360-360 J) Versus a Standard Escalating Energy Shock Protocol (125-150-200 J) in Cardioverting Atrial Fibrillation

Atrial fibrillation is the most common heart rhythm disorder. For patients suffering atrial fibrillation direct current cardioversion is performed to reduce patients symptoms and prevent disease progression. The optimal energy selection for biphasic cardioversion is unknown.

We aim to investigate the efficiency and safety of a high energy shock protocol (360 J) versus a standard escalating shock protocol (125-150-200 J) in cardioversion of atrial fibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The optimal energy selection for biphasic direct current (DC) cardioversion of atrial fibrillation is unknown. The energy delivered should be sufficient to achieve prompt cardioversion but without the risk of inducing any potential injury e.g. skin burns, myocardial stunning or post-cardioversion arrhythmias. The use of an escalating protocol, with a low energy initial shock, has been considered conventional practice, originally to avoid post cardioversion arrhythmias when using monophasic shocks.(1) This practice has been directly transferred to biphasic cardioversion. The European Society of Cardiology 2016 guidelines (2) and the American Heart Association/American College of Cardiology 2014 guidelines on the management of atrial fibrillation (3) do not recommend any specific energy settings, whereas the European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation (4) recommend a starting energy level of 120-200 J with subsequent escalating energy setting.

Previously, a non-escalating protocol (200 J) (5) has been found to have a significantly higher first shock success resulting in fewer shock deliveries without compromising safety compared with a low energy escalating shock protocol (100-150-200 J). Further, a study found fewer arrhythmic complications with increasing energy suggesting an 'upper limit of vulnerability'. It is well-established that biphasic shocks induce fewer post-shock arrhythmias (6), skin burns (7) and shorter periods of myocardial stunning compared with monophasic shocks.(8) Importantly, no correlation between increasing biphasic energy delivery and any complications was found in these studies. Nonetheless, the efficiency and safety of a high energy shock (360 J) biphasic protocol compared with a conventional low energy escalating protocol is unknown. Accordingly, this study aims to compare the efficiency and safety of a high energy protocol (360-360-360 J) versus a standard escalating protocol (125-150-200 J). We hypothesise that a high energy cardioversion protocol is more effective compared to standard escalating energy protocol, without compromising safety.

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Randers, Denmark, 8930
        • Randers Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years of age, scheduled for cardioversion of atrial fibrillation. Patients with atrial fibrillation for ≤48 hours may be cardioverted immediately. Patients with atrial fibrillation for >48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin.

Exclusion Criteria:

  • Pregnancy, haemodynamically unstable atrial fibrillation, other arrhythmias than atrial fibrillation, untreated hyperthyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard escalating shocks
Patients will be randomized to a standard escalating shock protocol using the energy settings: 125, 150, 200 J. All cardioversion attempts will be performed using LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA
Device: Standard escalating shocks
125 J, 150 J, 200 J
Other Names:
  • LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA
Active Comparator: High energy shocks
Patients will be randomized to a high energy shock protocol using the energy settings: 360, 360, 360 J. All cardioversion attempts will be performed using LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA
Device: High energy shock protocol
360 J, 360 J, 360 J.
Other Names:
  • LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Successful cardioversion
Time Frame: One minute following cardioversion
Successful cardioversion is defined as the proportion of patients in sinus rhythm one minute after cardioversion or cardioversion attempt (to a maximum of the 3 shocks in the protocol).
One minute following cardioversion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: First shock success
Time Frame: Following first cardioversion attempt
Successful cardioversion following the first cardioversion attempt (125 J versus 360 J).
Following first cardioversion attempt
Safety: Arrhythmic events and ECG-changes following cardioversion
Time Frame: Within four hours following cardioversion (until discharge)
Any post-cardioversion arrhythmias will be recorded using ECG-holtering four hours post cardioversion. Further ECG changes will be measured (sinus node dysfunction, atrioventricular delay, ventricular tachyarrhythmia or ventricular premature complexes, ST-segment deviations and recurrence of AF).
Within four hours following cardioversion (until discharge)
Safety: Skin-discomfort, skin burns or itching
Time Frame: Two hours after cardioversion
Patients self-assessment of skin discomfort and objective measurement of skin burns or itching.
Two hours after cardioversion
Safety: Troponin I level changes following cardioversion
Time Frame: Four hours after cardioversion
To evaluate changes in high sensitive cardiac troponin I levels between a baseline measurement before cardioversion and the level four hours following cardioversion.
Four hours after cardioversion
Safety: Echocardiographic evaluation following cardioversion
Time Frame: Two hours after cardioversion
Comparing a baseline echocardiographic evaluation with an evaluation performed two after cardioversion, e.g. left ventricular function using standard echocardiographic measurements.
Two hours after cardioversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Randers Regional Hospital

Investigators

  • Principal Investigator: Anders S Schmidt, MB, Randers Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

March 8, 2019

Study Completion (Actual)

March 8, 2019

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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