- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07610980
Optimal Shock Energy for Electrical Cardioversion of Atrial Fibrillation
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Presence of sinus rhythm in 1, 5 and 120 minutes after electrical shock.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cummulative shock energy
Zeitfenster: 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
Zeitfenster: 45 minutes
|
Levels of copeptin and cardiac troponin I or T will be assessed 45 minutes after electrical shock delivery.
|
45 minutes
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Prozesse
- Herzkrankheiten
- Arrhythmien, Herz
- Pathologische Zustände, Anzeichen und Symptome
- Vorhofflimmern
- Untersuchungstechniken
- Handhabung von Proben
- Klinische Labortechniken
- Diagnosetechniken und Verfahren
- Diagnose
- Punktionen
- Chirurgische Eingriffe, operativ
- Blutprobensammlung
Andere Studien-ID-Nummern
- MotolHomolkaUH
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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