Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jeroen Bosch Ziekenhuis | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm | Other | there is only one intervention arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duble current electro cardioversion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 60 minutes after cardioversion |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 1 hour after treatment |
| Incidence of treatment-emergent adverse events (Safety endpoint b) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Risco V Vliet, MSc | https://www.ravbrabantmwn.nl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAV Brabant MWN | 's-Hertogenbosch | North Brabant | 5212VM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40674510 | Derived | 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. |
Not provided
Not provided
Not provided
a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study.
Not provided
Not provided
Not provided
Not provided
|
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 |
| during 6 weeks follow-up |