CClinicalTrials.gg
Not yet recruitingNCT07610980Updated May 28, 2026

Optimal Shock Energy for Electrical Cardioversion of Atrial Fibrillation

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

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atrial Fibrillation (AF)

Browse trials for

03

In context

Atrial Fibrillation

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Atrial fibrillation
  • Atypical atrial flutter
  • Indication for elective electrical cardiac version made by independent physician

Exclusion criteria

Exclusion Criteria:

  • Typical atrial flutter
  • Focal atrial tachycardia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    200J protocol

    Protocol of 200-360-360J will be applied

    Procedure: Direct current biphasic electrical cardioversion · Diagnostic Test: blood sampling

  • Experimental
    360J protocol

    Protocol of 360-360-360J will be applied

    Procedure: Direct current biphasic electrical cardioversion · Diagnostic Test: blood sampling

  • Experimental
    Individual protocol

    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

Interventions

  • ProcedureDirect current biphasic electrical cardioversion

    Direct current biphasic electrical cardioversion using Lifepak 20e (Medtronic) external defibrilator will be applied in antero-lateral vector.

  • Diagnostic testblood sampling

    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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07610980
Lead sponsor
Motol and Homolka University Hospital
Responsible party
Jan Naar (Principal Investigator, Motol and Homolka University Hospital) — Principal investigator
First posted
May 28, 2026
Start date
May 18, 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Jun 2029 (estimated)
Last update
May 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion