Atrial Fibrillation Supraventricular arrhythmia
Conditions
Interventions
Compared to standard treatment for AF which consists of electrical
cardioversion in the hospital, RACE-6 will study cardioversion performed at
home. In fact this is an observational study applying a
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - safety endpoint: a composite of MACCE occurring within 24 hours - major adverse cardiovascular and cerebrovascular events (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 - number (%) of patients in sinus rhythm at the end of 6 weeks follow-up - inventory of all interventions in the study related to cost-of-care. | — |
Primary
| Measure | Time frame |
|---|---|
| There is one co-primary endpoint: Feasibility endpoint is completion of cardioversion (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC countershock was administered while the patient was under deep (propofol) sedation | — |
Countries
Netherlands
Outcome results
None listed