Comparison of High Versus Escalating Shocks in Cardioverting Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official 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

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Standard escalating shocks
* Device: High energy shock protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard escalating shocks<br>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<br>* 125 J, 150 J, 200 J<br>* Other names: LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA;|
| Active Comparator: High energy shocks<br>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<br>* 360 J, 360 J, 360 J.<br>* 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 | 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 | Successful cardioversion following the first cardioversion attempt (125 J versus 360 J). | Following first cardioversion attempt | 
| Safety: Arrhythmic events and ECG-changes following cardioversion | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardioversion