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Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation (DUAL-SHOCK)

1. maj 2026 opdateret af: Martín Negreira Caamaño

Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial

The goal of this clinical trial is to assess the efficacy and acute safety of the dual electrical cardioversion (ECV) technique compared with the conventional ECV in patients with persistent atrial fibrillation. The main question it aims to answer are:

  • Is dual ECV more effective than conventional ECV to achieve sinus rhythm restoration?
  • Is dual ECV safe compared with conventional ECV?
  • Which are the main factors associated with cardioversion success?

Researchers will compare a dual ECV technique with 400J with dual ECV with 200J and conventional ECV.

Participants will be randomized to one ECV configuration. The primary efficacy endpoint will be considered the percentage of patients with successful cardioversion with the first shock. The coprimary safety endpoint will be the occurrence of adverse events during ECV.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

177

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Diagnosis of persistent AF.
  • Effective anticoagulation for at least 3 weeks prior to the procedure or exclusion of intra-atrial thrombus by transesophageal echocardiography within the last 24 hours.
  • Informed consent obtained.

Exclusion Criteria:

  • Long-standing persistent atrial fibrillation (more than 1 year of uninterrupted AF rhythm).
  • Emergency indication (hemodynamic instability).
  • Cardiac defibrillation following catheter ablation procedures. Cardiac defibrillation performed during the same procedure will be permitted if it is carried out prior to ablation.
  • Pregnancy.
  • Age <18 years or legal incapacity.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Conventional Electrical Cardioversion
Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J
Procedure: Conventional Electrical Cardioversion

Defibrillation pads will be placed in the anteroposterior or anterolateral position. An initial biphasic shock of 200 J will be delivered. If sinus rhythm is not restored, a second dual shock of 400 J (crossover) will be administered.

The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and ECG-synchronized.
Eksperimentel: Dual-Shock 400J
ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 400J.
Procedure: Dual-shock Electrical Cardioversion

Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3.

The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and synchronized with the QRS complex.
Eksperimentel: Dual-Shock 200J
ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 200J.
Procedure: Dual-shock Electrical Cardioversion

Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3.

The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and synchronized with the QRS complex.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
Tidsramme: First minute after first shock delivery
Percentage of patients achieving sinus rhythm with the first shock deliver. Three consecutive beats in sinus rhythm are neccesary to consider sinus rhythm achieved.
First minute after first shock delivery
Primary Safety Outcome - Adverse events during the procedure
Tidsramme: Before patient are discharged
Ocurrence of any complication during the ECV. Arrhythmic recurrences of atrial fibrillation will not be considered as complications.
Before patient are discharged

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Procedural Sucess
Tidsramme: The end of the procedure
Percentage of patients achieving stable sinus rhythm after any number of shocks
The end of the procedure
Overall Intervention-Specific Success
Tidsramme: First minute after shock delivery
Number of successful shocks / Overall delivered shock within the same pad configuration.
First minute after shock delivery
Total Energy Delivered
Tidsramme: End of the procedure
Total energy administered (J) before the procedure is completed
End of the procedure
Sub-acute procedural success
Tidsramme: At 30 (25-35) days after the procedure
Percentage of patients in sinus rhythm at 30 days after the ECV
At 30 (25-35) days after the procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Martín Negreira Caamaño

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

27. februar 2028

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-129

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Study protocol will be sent for publication

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Atrieflimren

Kliniske forsøg med Conventional Electrical Cardioversion

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