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Atrial Fibrillation (AF)NCT07610980

Optimal Shock Energy for Electrical Cardioversion of Atrial Fibrillation

A study testing Direct current biphasic electrical cardioversion and blood sampling in people with Atrial Fibrillation (AF), run by Motol and Homolka University Hospital at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Direct current biphasic electrical cardioversion and blood sampling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteCzechia
Study dates
18 May 2026to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Typical atrial flutter
  • Focal atrial tachycardia

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jan Naar, MD, PhD contact

+420257272208

jan.naar@fnmh.cz

Czechia1 site, 1 recruiting
  • Motol and Homolka University Hospital, Homolka site

    Prague, 15030

    Jan Naar, MD, PhD, +420257272208, jan.naar@fnmh.cz

    Recruiting

Other trials in Czechia

About this study

Official title: Optimal Initial Shock Energy for Elective Direct Current Biphasic Electrical Cardioversion of Atrial Fibrillation

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.

Read more

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.

Being tested
Direct current biphasic electrical cardioversion, blood sampling
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct current biphasic electrical cardioversionProcedure or surgery

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

  • blood samplingDiagnostic test

    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.

Study groups in NCT07610980
Study groupRoleWhat they receive
200J protocolExperimentalProtocol of 200-360-360J will be applied
Receives: Procedure: Direct current biphasic electrical cardioversion; Diagnostic Test: blood sampling
360J protocolExperimentalProtocol of 360-360-360J will be applied
Receives: Procedure: Direct current biphasic electrical cardioversion; Diagnostic Test: blood sampling
Individual protocolExperimentalProtocol 200-360-360J or 360-360-360J will be selected according to other criteria
Receives: Procedure: Direct current biphasic electrical cardioversion; Diagnostic Test: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 2 hours

Secondary outcomes (2)
  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.

    Measured: 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.

    Measured: 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start18 May 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07610980
Sponsor's protocol ID
MotolHomolkaUH
Status last verified
Oct 2026
First submitted
13 May 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Direct current biphasic electrical cardioversion and blood sampling in people with Atrial Fibrillation (AF), run by Motol and Homolka University Hospital at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jan Naar, MD, PhD (+420257272208, jan.naar@fnmh.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of sinus rhythm in 1, 5 and 120 minutes after electrical shock. (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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