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Completed

NCT Number: NCT02923414

Comparison of High Versus Escalating Shocks 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Randers Regional Hospital

Randers, 8930, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard escalating shocks

Device

125 J, 150 J, 200 J

Other names: LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA

High energy shock protocol

Device

360 J, 360 J, 360 J.

Other names: LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA

Primary outcomes

  1. 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).

Secondary outcomes

  1. Efficacy: First shock success

    Time frame: Following first cardioversion attempt

    Successful cardioversion following the first cardioversion attempt (125 J versus 360 J).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Randers Regional Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2016
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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