Clinical trial NCT06322836: A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home
Official title: Electra-1; Elective Cardioversion of Atrial Fibrillation at Home by Advanced Practice Providers; A Feasibility Study in Dutch Emergency Medical Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Medical Services
Electric Countershock
Keywords: atrial fibrilation
DC-ECV
Lead sponsor: RAV Brabant MWN
Sponsor class: OTHER
Collaborators: name: Jeroen Bosch Ziekenhuis
First posted: 2024-03-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: completion of cardioversion to sinus rhythm
timeFrame: within 60 minutes after cardioversion
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (Safety endpoint a)
timeFrame: up to 1 hour after treatment
measure: Incidence of treatment-emergent adverse events (Safety endpoint b)
timeFrame: during 6 weeks follow-up
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: RAV Brabant MWN
state: Noord Brabant
Study officials:
affiliation: https://www.ravbrabantmwn.nl
name: Risco V Vliet, MSc
role: PRINCIPAL_INVESTIGATOR
References: