Emergency Medical ServicesElectra-1NCT06322836
A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home
A study testing Duble current electro cardioversion in people with Emergency Medical Services and Electric Countershock, run by RAV Brabant MWN at 1 site in Netherlands.
Trial summary
The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergency Medical Services, Electric Countershock
- What is being tested?
- Duble current electro cardioversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Feb 2024to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age 18 -75 year subjects, able to understand the provided information and sign an informed consent.
- Need for direct current electrical cardioversion (DC-ECV) for correction of recurrent symptomatic AF (according to the guidelines of the American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC)).
- Weight more than 50 kilograms.
- Successful hospital DC-ECV for a previous episode of AF performed under propofol sedation.
- Target range of international normalized ratio (INR) above 2.0, when on vitamin K antagonists, or use of novel oral anticoagulant, stable for 3 weeks.
Show all 9Show fewer
- ASA 2.
- BMI < 35 kg/m2.
- Fasting status: at least 6 hours for food, and 2 hours for fluids.
Who cannot join
- 1. Patients over 75 years old and younger than 18 years. 2. Patients wearing pacemaker or implantable cardioverter-defibrillator. 3. Patients with (cardiovascular): sick sinus syndrome, ventricular pre-excitation, Brugada syndrome or bundle branch block.
- severe ischemic or valvular heart disease. known second or third degree atrioventricular block normal sinus rhythm. heart failure NYHA III or IV, known LVEF < 35%, or cor pulmonale. transient and reversible cause of AF, e.g. in setting of fever and hyperthyroidism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electra-1; Elective Cardioversion of Atrial Fibrillation at Home by Advanced Practice Providers; A Feasibility Study in Dutch Emergency Medical Service
The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.
The main question[s] it aims to answer are:
Read more
Primary objective:
In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).
Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.
Secondary objectives:
Safety endpoint:
Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).
A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.
- Conditions
- Emergency Medical Services, Electric Countershock
- Being tested
- Duble current electro cardioversion
- Keywords
- atrial fibrilation, DC-ECV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duble current electro cardioversionProcedure or surgery
Instead of the regular clinical treatment, in this study direct-current electrical cardioversion (DC-ECV) will be performed at the patient's home and will be carried out by well-trained and certified advanced practice providers (APP) on site, i.e. nurse practitioner or physician assistant, supported by an EMS ambulance team containing an ambulance nurse and ambulance driver, both trained advanced life-support (ALS) professionals.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Other | there is only one intervention arm Receives: Procedure: Duble current electro cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
completion of cardioversion to sinus rhythm
% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation
Measured: within 60 minutes after cardioversion
Secondary outcomes (2)
Incidence of treatment-emergent adverse events (Safety endpoint a)
Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).
Measured: up to 1 hour after treatment
Incidence of treatment-emergent adverse events (Safety endpoint b)
A composite of major adverse cardiovascular and cerebrovascular events (MACCE) during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up
Measured: during 6 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start7 Feb 2024
- Primary completion29 Aug 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Medical ServicesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAV Brabant MWN
- Sponsor type
- University, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Responsible party
- Principal investigator, Risco van Vliet, RAV Brabant MWN
- Investigators
- Risco V Vliet, MSc, Principal investigator, https://www.ravbrabantmwn.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322836
- Sponsor's protocol ID
- Protocol ID ABR number 83536
- Acronym
- Electra-1
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Vliet R, van Eck M, Wieringa WG, Moors XRJ, van 't Hof AWJ. Elective cardioversion of atrial fibrillation at home by advanced practice providers: a feasibility study in the Dutch emergency medical service-design and pilot results. Eur J Cardiovasc Nurs. 2025 Dec 29;24(8):1324-1330. doi: 10.1093/eurjcn/zvaf140.
PubMed 40674510
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electra-1; Elective Cardioversion of Atrial Fibrillation at Home by Advanced Practice Providers; A Feasibility Study in Dutch Emergency Medical Service
- ClinicalTrials.gov ID
- NCT06322836
- Acronym / sponsor ID
- Electra-1 / Protocol ID ABR number 83536
- Conditions
- Emergency Medical Services, Electric Countershock
- Keywords
- atrial fibrilation, DC-ECV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- RAV Brabant MWNUniversity, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 21 Mar 2024 (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 pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.
The main question[s] it aims to answer are:
Primary objective:
In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).
Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.
Secondary objectives:
Safety endpoint:
Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).
A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study.
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Other | Procedure: Duble current electro cardioversionthere is only one intervention arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent.
- Age 18 -75 year subjects, able to understand the provided information and sign an informed consent.
- Need for direct current electrical cardioversion (DC-ECV) for correction of recurrent symptomatic AF (according to the guidelines of the American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC)).
- Weight more than 50 kilograms.
- Successful hospital DC-ECV for a previous episode of AF performed under propofol sedation.
Key exclusion criteria (2 listed)
- 1. Patients over 75 years old and younger than 18 years. 2. Patients wearing pacemaker or implantable cardioverter-defibrillator. 3. Patients with (cardiovascular): sick sinus syndrome, ventricular pre-excitation, Brugada syndrome or bundle branch block.
- severe ischemic or valvular heart disease. known second or third degree atrioventricular block normal sinus rhythm. heart failure NYHA III or IV, known LVEF < 35%, or cor pulmonale. transient and reversible cause of AF, e.g. in setting of fever and hyperthyroidism.
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 |
|---|---|---|
| Duble current electro cardioversionInstead of the regular clinical treatment, in this study direct-current electrical cardioversion (DC-ECV) will be performed at the patient's home and will be carried out by well-trained and certified advanced practice providers (APP) on site, i.e. nurse practitioner or physician assistant, supported by an EMS ambulance team containing an ambulance nurse and ambulance driver, both trained advanced life-support (ALS) professionals. | Procedure or surgery | intervention arm |
Primary outcome
completion of cardioversion to sinus rhythm
Time frame: within 60 minutes after cardioversion
% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation
2 secondary outcomes
Incidence of treatment-emergent adverse events (Safety endpoint a)
Time frame: up to 1 hour after treatment
Incidence of treatment-emergent adverse events (Safety endpoint b)
Time frame: during 6 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 40674510van Vliet R, van Eck M, Wieringa WG, Moors XRJ, van 't Hof AWJ. Elective cardioversion of atrial fibrillation at home by advanced practice providers: a feasibility study in the Dutch emergency medical service-design and pilot results. Eur J Cardiovasc Nurs. 2025 Dec 29;24(8):1324-1330. doi: 10.1093/eurjcn/zvaf140.
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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. This study is not recruiting at the moment.
Risco V Vliet, MSc principal investigator
https://www.ravbrabantmwn.nl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duble current electro cardioversion in people with Emergency Medical Services and Electric Countershock, run by RAV Brabant MWN at 1 site in Netherlands.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
completion of cardioversion to sinus rhythm (time frame: within 60 minutes after cardioversion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06322836, which also lists 1 linked publication.
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 11 Apr 2025.