A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home

NCT06322836 | Completed

• 1 other identifier: Protocol ID ABR number 83536
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Emergency Medical Services; Electric Countershock

Keywords

atrial fibrilation; DC-ECV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Incidence of treatment-emergent adverse events (Safety endpoint a)

  up to 1 hour after treatment

• Incidence of treatment-emergent adverse events (Safety endpoint b)

  during 6 weeks follow-up

Study Arms (1)

intervention arm

OTHER

there is only one intervention arm

Procedure: Duble current electro cardioversion

Interventions

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.

intervention arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ASA 2.
• BMI \< 35 kg/m2.
• Fasting status: at least 6 hours for food, and 2 hours for fluids.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• RAV Brabant MWN: lead
• Jeroen Bosch Ziekenhuis: collaborator

Study Sites (1)

RAV Brabant MWN

's-Hertogenbosch, North Brabant, 5212VM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40674510 DERIVED

Study Officials

• Risco V Vliet, MSc

  https://www.ravbrabantmwn.nl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 21, 2024
• Study Start: February 7, 2024
• Primary Completion: August 29, 2024
• Study Completion: February 10, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

NL (1)