atrial fibrilation
Conditions
Interventions
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 certifie
Sponsors
Jeroen Bosch ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 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
Exclusion criteria
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 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objectives of this feasibility study focuses on; (a) can a home DC-ECV be done, (b) evaluation of enrollment of participants, (c) evaluation and refinement of data and outcome collection procedures, (d) 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
| Measure | Time frame |
|---|---|
| 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; ; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care. | — |
Countries
Netherlands
Outcome results
None listed