NCT07174986

Brief Summary

Some of the patients affected by Out-of-hospital cardiac arrest (OHCA) with ventricular fibrillation (VF)/ventricular tachycardia (VT) do not respond to initial defibrillation. The survival decreases with number of defibrillations required to terminate VF/VT. In 2022, one prospective cluster randomized trial showed increased survival among (OHCA) patients in refractory VF using Double Sequential Defibrillation (DSD). If DSD can increase survival among all patients in VF that dont respond to one defibrillation, i.e. before it has become refractory is not known. The aim of this trial is to assess survival with a double defibrillation strategy initiated as soon as possible among patients with Out of Hospital Cardiac Arrest with initial shockable rhythm and at least one failed standard defibrillation, compared with continued resuscitation using standard defibrillation.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
916

participants targeted

Target at P75+ for phase_2

Timeline
43mo left

Started Sep 2025

Typical duration for phase_2

Geographic Reach
3 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Sep 2025Dec 2029

First Submitted

Initial submission to the registry

September 3, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

September 3, 2025

Last Update Submit

February 12, 2026

Conditions

Ventricular FibrillationDefibrillationCPRACLSSudden DeathOut of Hospital Cardiac Arrest

Keywords

Double sequential defibrillationDouble sequential external defibrillationACLS

Outcome Measures

Primary Outcomes (1)

  • 30 day survival

    Survival at 30 days

    30 days

Secondary Outcomes (4)

  • ROSC

    1 day

  • Survival to hospital Admission

    1 day

  • Survival to hospital discharge

    30 days

  • Neurological function at hospital discharge, mRS (modified Ranking scale, 1-6 where 1 indicates better function)

    30 days

Other Outcomes (7)

  • 90 days survival

    90 days

  • Neurological function at 90 days (mRS)

    90 days

  • Helath related quality of life at 90 days

    90 days

  • +4 more other outcomes

Study Arms (2)

Early Double sequential defibrillation

EXPERIMENTAL

If the patient is randomized to the DSD group, the ambulance crew team will apply the second defibrillator with electrodes placed in the A-P position as soon as possible. Defibrillation is performed by one person defibrillating both defibrillators in a sequential manner "Double Sequential Defibrillation" (DSD). All consecutive defibrillations will thereafter be performed with the DSD strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.

Device: Double sequential defibirllation

Standard defibrillation

ACTIVE COMPARATOR

If the patient is randomized to the standard defibrillation group, the ambulance crew team will continue Advanced life support in accordance with standard of care and continue to perform standard defibibrillation using one defibrillator. All consecutive defibrillations will thereafter be performed with the standard defibrillation strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.

Device: Standard defibrillation

Interventions

Double sequential defibirllationDEVICE

A second defibrillator will be applyed with electrodes placed in the A-P position and defibrillation will be performed with two defibrllators in a sequential manner

Also known as: DSD
Early Double sequential defibrillation
Standard defibrillationDEVICE

Standard defibrillation uning one defibrillator

Standard defibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OHCA patients with VT/VF at first rhythm analysis and at least one defibrillation performed in standard (A-L) position

You may not qualify if:

  • Age \< 18 years
  • Obvious pregnancy
  • Known preexisting Do Not Attempt Resuscitation order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

ARREST (AmsteRdam REsuscitation STudies)

Amsterdam, Netherlands

NOT YET RECRUITING

Centro de Emergencias 061 Andalucía

Málaga, Andalusia, 29560, Spain

NOT YET RECRUITING

Médico Emergencias Osakidetza EMERGENTZIAK

Bilbao, Baque Country, 48004, Spain

NOT YET RECRUITING

Sistema de Emergencias Medicas de Catalunya

Barcelona, Catalonia, 08908, Spain

NOT YET RECRUITING

SUMMA 112 Emergency medical services

Madrid, Madrid, 28045, Spain

NOT YET RECRUITING

Ambulanssjukvården, Region Halland

Halmstad, Halland County, Sweden

RECRUITING

Ambulanssjukvården Region Värmland

Karlstad, Värmland County, 65230, Sweden

RECRUITING

Ambulanshelikoptern (HEMS) Västra Götalandsregionen

Kungälv, Västra Götaland County, 442 83, Sweden

RECRUITING

Sjukvården i väster

Alingsås, Sweden

RECRUITING

Emergency medical services, Södra Älvsborgs Sjukhus, Region Västra Götaland

Borås, 501 82, Sweden

RECRUITING

Prehospital Intensive Care Unit (PIV) AnOPIVA Östra Sjukhuset/SU

Gothenburg, Sweden

RECRUITING

Shalgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Ambulanssjukvården Skaraborgs Sjukhus, Västra Götalandsregionen (SKAS)

Skövde, Sweden

RECRUITING

Emergency medical services NU-Sjukvården, Region Västra Götaland

Trollhättan, 461 85, Sweden

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestVentricular FibrillationDeath, Sudden

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsDeath

Study Officials

  • Gabriel Riva, M.D. Ph.D.

    Center for resuscitation Science. Department of clinical sience and education. Södersjukhuset, Karolinksa Institutet, Stockholm, Sweden

    STUDY DIRECTOR

  • Akil Awad, M.D. Ph.D.

    Center for resuscitation Science. Department of clinical sience and education. Södersjukhuset, Karolinksa Institutet, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

  • Carl Magnusson, R.N., Ph.D.

    Shalgrenska University Hospital

    STUDY CHAIR

  • Andreas Claesson, R.N. Ph.D.

    Center for resuscitation Science. Department of clinical sience and education. Södersjukhuset, Karolinksa Institutet, Stockholm, Sweden

    STUDY CHAIR

  • Johan Israelsson, R.N. Ph.D.

    ICARE, Department of Health and Caring Sciences, Linnaeus University

    STUDY CHAIR

Central Study Contacts

Gabriel Riva, M.D. Ph.D

CONTACT

+ 47 70 545 20 86gabriel.riva@ki.se

Akil Awad, M.D. Ph.D.

CONTACT

(+46) 070 400 13 63akil.awad@ki.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Academic, investigator initiated, open-label pilot study with a randomized controlled trial (RCT) design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 16, 2025

Study Start

September 8, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

SE(9)NL(1)ES(4)