An interventional study of Direct current biphasic electrical cardioversion and blood sampling in Atrial Fibrillation (AF), sponsored by Motol and Homolka University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Motol and Homolka University Hospital · Not applicable, Interventional, and Treatment
Introduction For elective electrical cardioversion of atrial fibrillation, the recommended standard is the administration of a biphasic direct current shock. However, there is considerable variability among physicians regarding the choice of the initial shock energy, as current clinical guidelines do not specify it precisely. The guidelines of American cardiology societies recommend a shock intensity of at least 200 J, while the European Society of Cardiology guidelines do not comment on shock energy at all.
Evidence from a previous randomized clinical trial has shown that using a higher initial shock energy (360 J) is more effective, safe, and reduces the cumulative delivered energy, since lower initial shock energy more frequently requires repeated shocks. The safety of the maximal-energy protocol was demonstrated in this study, among other by the absence of myocardial injury as assessed by cardiac troponin I levels measured 4 hours after electrical cardioversion. However, in this study, the maximal initial shock energy protocol was compared with a low-energy escalating protocol (125-150-200 J), which is no longer supported by current clinical guidelines.
Objective The primary objective of the study is to compare the efficacy (short-term maintenance of sinus rhythm and the need for repeated shocks) of two regimens commonly used in clinical practice: 200-360-360 J and 360-360-360 J.
Secondary objectives are to identify factors that would justify the use of either lower or higher initial shock energy. Another secondary objective is to confirm the safety of the maximal initial shock energy protocol by assessing the biomarker of acute stress (copeptin) in a subpopulation of patients (n = 60).
Methods The main inclusion criterion for the study is the presence of atrial fibrillation or atypical atrial flutter and a clinical indication for electrical cardioversion raised an independent cardiologist. The main exclusion criterion is the presence of typical atrial flutter or focal atrial tachycardia, for which lower shock energy is recommended.
This is a prospective, randomized, single-blind (patient) study in which patients will be randomly assigned in a 1:1:1 ratio either to (i) 200-360-360 J protocol, (ii) 360-360-360 J protocol, or (iii) individualized selection of one of the above protocols based on additional parameters. I one of parameters next parameters is met, the 360-360-360 J protocol will be applied, if not, the 200-360-360 J protocol will be applied: Left atrial size > 55 mm, duration of the arrhythmia > 12 months, BMI > 30 kg/m2, chest circumference > 120 cm.
Since chest dimensions and the amount of subcutaneous fat may influence resistance to electrical current and thereby reduce the delivered electrical energy, chest dimensions and configuration will be evaluated prior to electrical cardioversion in addition to height and weight. The procedure itself (electrical cardioversion) will then be performed according to the standard institutional clinical practice.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 400 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Motol and Homolka University Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Protocol of 200-360-360J will be applied
Procedure: Direct current biphasic electrical cardioversion · Diagnostic Test: blood sampling
Protocol of 360-360-360J will be applied
Procedure: Direct current biphasic electrical cardioversion · Diagnostic Test: blood sampling
Protocol 200-360-360J or 360-360-360J will be selected according to other criteria
Procedure: Direct current biphasic electrical cardioversion · Diagnostic Test: blood sampling
Direct current biphasic electrical cardioversion using Lifepak 20e (Medtronic) external defibrilator will be applied in antero-lateral vector.
6 mL blood samples will be taken from periferal vein before electrical cardiac version and 45 minutes after electrical cardiac version to assess biomarkers of stress and myocardial injury in 60 subjects.
Presence of sinus rhythm in 1, 5 and 120 minutes after electrical shock.
Presence of sinus rhythm will be assessed by experienced cardiologist using 3-lead ECG monitor (IntelliVue MP, Philips). If it cannot be concluded about the presence of sinus rhythm from 3-lead ECG monitor, standard 12-lead ECG will be performed using SE-1200 Express machine (EDAN).
Time frame: 2 hours
Cummulative shock energy
Mean shock energy per intervention will be calculated in each arm as a sum of energies of all shocks delivered during one procedure divided by number of procedures.
Time frame: 5 minutes
Myocardial stress and injury
Levels of copeptin and cardiac troponin I or T will be assessed 45 minutes after electrical shock delivery.
Time frame: 45 minutes
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.