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Optimal Shock Energy for Electrical Cardioversion of Atrial Fibrillation

20 maj 2026 uppdaterad av: Jan Naar, Motol and Homolka University Hospital

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.

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

400

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • Typical atrial flutter
  • Focal atrial tachycardia

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 200J protocol
Protocol of 200-360-360J will be applied
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.
Experimentell: 360J protocol
Protocol of 360-360-360J will be applied
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.
Experimentell: Individual protocol
Protocol 200-360-360J or 360-360-360J will be selected according to other criteria
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Presence of sinus rhythm in 1, 5 and 120 minutes after electrical shock.
Tidsram: 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 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cummulative shock energy
Tidsram: 5 minutes
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.
5 minutes
Myocardial stress and injury
Tidsram: 45 minutes
Levels of copeptin and cardiac troponin I or T will be assessed 45 minutes after electrical shock delivery.
45 minutes

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

18 maj 2026

Primärt slutförande (Beräknad)

1 december 2028

Avslutad studie (Beräknad)

1 juni 2029

Studieregistreringsdatum

Först inskickad

13 maj 2026

Först inskickad som uppfyllde QC-kriterierna

20 maj 2026

Första postat (Faktisk)

28 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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