A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home

Emergency Medical Services Clinical Trial

— Electra-1  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06322836
• Other study ID #: Protocol ID ABR number 83536
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: RAV Brabant MWN
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent.

2. Age 18 -75 year subjects, able to understand the provided information and sign an informed consent.

3. 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)).

4. Weight more than 50 kilograms.

5. Successful hospital DC-ECV for a previous episode of AF performed under propofol sedation.

6. 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.

7. ASA 2.

8. BMI < 35 kg/m2.

9. 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Electric Countershock
• Emergencies
• Emergency Medical Services

Intervention

Procedure:
• Duble current electro cardioversion
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.

Locations

Country	Name	City	State
Netherlands	RAV Brabant MWN	's-Hertogenbosch	Noord Brabant

Sponsors (2)

Lead Sponsor	Collaborator
RAV Brabant MWN	Jeroen Bosch Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	during 6 weeks follow-up