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

Withdrawn

Conditions: Atrial Fibrillation
Supraventricular arrhythmia
10007521

Registration Number: NL-OMON39850

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

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

Secondary Outcome Measures

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