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.
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.
Czechia1 site, 1 recruiting
- Recruiting
Motol and Homolka University Hospital, Homolka site
Prague, 15030
Jan Naar, MD, PhD, +420257272208, jan.naar@fnmh.cz
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.
- Conditions
- Atrial Fibrillation (AF)
- 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 group | Role | What they receive |
|---|---|---|
| 200J protocol | Experimental | Protocol of 200-360-360J will be applied Receives: Procedure: Direct current biphasic electrical cardioversion; Diagnostic Test: blood sampling |
| 360J protocol | Experimental | Protocol of 360-360-360J will be applied Receives: Procedure: Direct current biphasic electrical cardioversion; Diagnostic Test: blood sampling |
| Individual protocol | Experimental | Protocol 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.
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)
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
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.
- First posted28 May 2026
- Study start18 May 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Motol and Homolka University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Naar, Motol and Homolka University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Initial Shock Energy for Elective Direct Current Biphasic Electrical Cardioversion of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07610980
- Acronym / sponsor ID
- MotolHomolkaUH
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Motol and Homolka University HospitalUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200J protocol | Experimental | Procedure: Direct current biphasic electrical cardioversion, Diagnostic Test: blood samplingProtocol of 200-360-360J will be applied |
| 360J protocol | Experimental | Procedure: Direct current biphasic electrical cardioversion, Diagnostic Test: blood samplingProtocol of 360-360-360J will be applied |
| Individual protocol | Experimental | Procedure: Direct current biphasic electrical cardioversion, Diagnostic Test: blood samplingProtocol 200-360-360J or 360-360-360J will be selected according to other criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Atrial fibrillation
- Atypical atrial flutter
- Indication for elective electrical cardiac version made by independent physician
Key exclusion criteria (2 listed)
- Typical atrial flutter
- Focal atrial tachycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct current biphasic electrical cardioversionDirect current biphasic electrical cardioversion using Lifepak 20e (Medtronic) external defibrilator will be applied in antero-lateral vector. | Procedure or surgery | 200J protocol, 360J protocol, Individual protocol |
| blood sampling6 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. | Diagnostic test | 200J protocol, 360J protocol, Individual protocol |
Primary outcome
Presence of sinus rhythm in 1, 5 and 120 minutes after electrical shock.
Time frame: 2 hours
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).
2 secondary outcomes
Cummulative shock energy
Time frame: 5 minutes
Myocardial stress and injury
Time frame: 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.