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NCT Number: NCT06322836

A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home

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.

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Key information

Conditions

Emergency Medical Services Electric Countershock

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAV Brabant MWN

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: up to 1 hour after treatment

    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).

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

    Time frame: during 6 weeks follow-up

    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

Sponsors and collaborators

Lead sponsor

RAV Brabant MWN

Other

Collaborators

  • Jeroen Bosch Ziekenhuis

Registry information

Official study title

Electra-1; Elective Cardioversion of Atrial Fibrillation at Home by Advanced Practice Providers; A Feasibility Study in Dutch Emergency Medical Service

Acronym: Electra-1

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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