Symptomatic recurrent persistent Atrial fibrillation Electro cardiversion Home based cardiac intervention Emergency Care Practitioners In Dutch: Recidief symptomatisch persisterend atriumfibrilleren Electrische cardioversie Cardiale thuisinterventie Verpleegkundig specialist acute zorg
Conditions
Interventions
Race-6 is an observational pilot study during 6 weeks, without a control group. The intervention deployed is a standard electrical cardioversion performed in the home environment of the patients.
In
Sponsors
Academisch ziekenhuis Maastricht (azM)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Signed informed consent; 2.Age 20-75 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 persistent 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 persistent 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 1 and 2; 8.BMI < 35 kg/m2;
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1.Patients over 75 years old and younger than 20; 2.Patients wearing pacemaker or implantable cardioverter-defibrillator; 3.Patients with (cardiovascular): „Xsick sinus syndrome, ventricular pre-excitation, Brugada syndrome or bundle branch block „Xsevere ischemic or valvular heart disease „Xdilated or hypertrophic cardiomyopathy „Xsecond or third degree atrioventricular block „Xheart failure NYHA III or IV, known LVEF < 35%, or cor pulmonale „Xtransient and reversible cause of AF, e.g. in setting of fever and hyperthyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this observational feasibility and safety study in 30 patients the (a) 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 sedation; (b) safety endpoint: a composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours (subdivided in early MACCE, i.e. during the first hour observation period and late MACCE, i.e. thereafter up till 24 hours). 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 sedation); | — |
Secondary
| Measure | Time frame |
|---|---|
| A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours (subdivided in early MACCE, i.e. during the first hour observation period and late MACCE, i.e. thereafter up till 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. | — |
Contacts
Public ContactH.J.G.M Crijns
Postbus 5800
Outcome results
None listed