RegionAl Home CardiovErsion study of atrial fibrillation. Pilot study on feasibility.

Recruiting

Conditions: Atrial Fibrillation
Supraventricular arrhythmia
10007521

Registration Number: NL-OMON50670

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

In order to be included in the study, the patients need to have had a previous
successful hospital DC-ECV under propofol sedation. Patients aged (20-75 years)
with a recurrence of symptomatic persistent AF without hemodynamic instability
or other severe co-morbidities requiring DC-ECV (according to ESC guidelines )
are enrolled in the study, after prior uncomplicated hospital DC-ECV. A written
informed consent will be obtained.

Exclusion Criteria

The exclusion criteria are as follows: Patients over 75 years old (and younger
than 20 years), patients wearing pacemaker or implantable
cardioverter-defibrillator and patients with severe co-morbidities (liver
disease, kidney impairment, pulmonary dysfunction, malignancies, connective
tissue disease, inflammatory disease such as peri-myocarditis) are excluded
from participating in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>There is one co-primary endpoint: Feasibility endpoint is completion of<br /><br>cardioversion (% of study patients with a recurrence of AF in whom a home<br /><br>cardioversion is performed, i.e. to whom at least one DC countershock was<br /><br>administered while the patient was under deep (propofol) sedation </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: - safety endpoint: a composite of MACCE occurring within<br /><br>24 hours - major adverse cardiovascular and cerebrovascular events (MACCE)<br /><br>occurring during 6 weeks follow-up - any hospitalisation and all-cause<br /><br>mortality during 6 weeks follow-up - number (%) of patients in sinus rhythm at<br /><br>1 hour in the post-shock observation period - number (%) of patients in sinus<br /><br>rhythm at the end of 6 weeks follow-up - inventory of all interventions in the<br /><br>study related to cost-of-care.</p><br>