Atrial Fibrillation (AF)Phase 2/3DUAL-SHOCKNCT07560644
Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation
A Phase 2/3 study testing Conventional Electrical Cardioversion and Dual-shock Electrical Cardioversion in people with Atrial Fibrillation (AF) and Atrial Fibrillation, run by Martín Negreira Caamaño, MD, PhD.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation
- What is being tested?
- Conventional Electrical Cardioversion and Dual-shock Electrical Cardioversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 27 Feb 2028
- Phase
- Phase 2/3
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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.
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation
- Being tested
- Conventional Electrical Cardioversion, Dual-shock Electrical Cardioversion
- Keywords
- Atrial fibrillation, Persistant atrial fibrillation, Electrical Cardioversion, Dual-Shock, Sinus Rhythm
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Electrical CardioversionProcedure or surgery
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.
Dual-shock Electrical CardioversionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Electrical Cardioversion | Active comparator | Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J Receives: Procedure: Conventional Electrical Cardioversion |
| Dual-Shock 400J | Experimental | ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 400J. Receives: Procedure: Dual-shock Electrical Cardioversion |
| Dual-Shock 200J | Experimental | ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 200J. Receives: Procedure: Dual-shock Electrical Cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
Percentage of patients achieving sinus rhythm with the first shock deliver. Three consecutive beats in sinus rhythm are neccesary to consider sinus rhythm achieved.
Measured: First minute after first shock delivery
Primary Safety Outcome - Adverse events during the procedure
Ocurrence of any complication during the ECV. Arrhythmic recurrences of atrial fibrillation will not be considered as complications.
Measured: Before patient are discharged
Secondary outcomes (4)
Overall Procedural Sucess
Percentage of patients achieving stable sinus rhythm after any number of shocks
Measured: The end of the procedure
Overall Intervention-Specific Success
Number of successful shocks / Overall delivered shock within the same pad configuration.
Measured: First minute after shock delivery
Total Energy Delivered
Total energy administered (J) before the procedure is completed
Measured: End of the procedure
Sub-acute procedural success
Percentage of patients in sinus rhythm at 30 days after the ECV
Measured: At 30 (25-35) days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion27 Feb 2028 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Eligible patients will be randomized in a 1:1:1 ratio to one of three treatment groups: standard ECV, dual ECV with 400 J, or dual ECV with 200 J. Patients randomized to receive standard ECV will be further randomized in a 1:1 ratio to receive either an anteroposterior or anterolateral first shock. The initial randomization will be stratified by the presence of obesity (body mass index \>30 kg/m²) and by prior use of antiarrhythmic drugs.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martín Negreira Caamaño, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martín Negreira Caamaño, MD, PhD, Hospital Universitario Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560644
- Sponsor's protocol ID
- 25-129
- Acronym
- DUAL-SHOCK
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be sent for publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial
- ClinicalTrials.gov ID
- NCT07560644
- Acronym / sponsor ID
- DUAL-SHOCK / 25-129
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation
- Keywords
- Atrial fibrillation, Persistant atrial fibrillation, Electrical Cardioversion, Dual-Shock, Sinus Rhythm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Martín Negreira Caamaño, MD, PhDUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 27 Feb 2028 (estimated)
- First posted
- 1 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Eligible patients will be randomized in a 1:1:1 ratio to one of three treatment groups: standard ECV, dual ECV with 400 J, or dual ECV with 200 J. Patients randomized to receive standard ECV will be further randomized in a 1:1 ratio to receive either an anteroposterior or anterolateral first shock. The initial randomization will be stratified by the presence of obesity (body mass index >30 kg/m²) and by prior use of antiarrhythmic drugs.
| Arm | Type | Receives |
|---|---|---|
| Conventional Electrical Cardioversion | Active comparator | Procedure: Conventional Electrical CardioversionConventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J |
| Dual-Shock 400J | Experimental | Procedure: Dual-shock Electrical CardioversionECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 400J. |
| Dual-Shock 200J | Experimental | Procedure: Dual-shock Electrical CardioversionECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 200J. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Conventional Electrical CardioversionDefibrillation 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. | Procedure or surgery | Conventional Electrical Cardioversion |
| Dual-shock Electrical CardioversionTwo 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. | Procedure or surgery | Dual-Shock 200J, Dual-Shock 400J |
Primary outcome
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
Time frame: 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.
Primary Safety Outcome - Adverse events during the procedure
Time frame: Before patient are discharged
Ocurrence of any complication during the ECV. Arrhythmic recurrences of atrial fibrillation will not be considered as complications.
4 secondary outcomes
Overall Procedural Sucess
Time frame: The end of the procedure
Overall Intervention-Specific Success
Time frame: First minute after shock delivery
Total Energy Delivered
Time frame: End of the procedure
Sub-acute procedural success
Time frame: At 30 (25-35) days after the procedure
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Study protocol will be sent for publication
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Conventional Electrical Cardioversion and Dual-shock Electrical Cardioversion in people with Atrial Fibrillation (AF) and Atrial Fibrillation, run by Martín Negreira Caamaño, MD, PhD.
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 5 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: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Martín Negreira-Caamaño, MD, PhD (+34 916839360, martin.negcam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock (time frame: First minute after first shock delivery). The study lists 2 primary outcomes in all. 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 28 Jul 2026.