The aim of this pilotstudy is to obtain data regarding feasibility, safety and costs of home-based electrical cardioversion
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
sedation
Secondary outcome
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
Background summary
Atrial fibrillation (AF) is associated with significant cardiovascular
morbidity and mortality, especially with ageing of the population. The economic
impact of AF on health care resources is increasing significantly. Nowadays
prompt service is hard to provide in many institutions due to logistic
difficulties around cardioversion (shortage of beds, limited number of
personnel, problematic control of the INR and workload of the staff).
Based on previous international studies of outpatient management - successfully
and safely conducted through either a nurse-led or a physician-led strategy -
we designed the present pilotstudy in order to assess both feasibility and
safety of home DC-ECV in the management of recurrent symptomatic persistent AF
performed by emergency care practitioners (ECPs). We postulate that this home
policy is feasible and safe and associated with low costs compared to
hospital-based cardioversion. This model will release the pressure on the
limited number of acute hospital beds and unload the pressure of the heavily
loaded junior staff members.
Study objective
The aim of this pilotstudy is to obtain data regarding feasibility, safety and
costs of home-based electrical cardioversion
Study design
The study is designed as a pilot, open-label, non-controlled, non-randomised,
single centre study.
Eligible patients who attended the Coronary Care Unit (CCU) of Hospital Group
Twente, the Netherlands for elective day-case DC-ECV of symptomatic persistent
atrial fibrillation are asked to participate in this pilot study, for a
potential future home DC-ECV in case a recurrent episode occurs, after a
previous successful in-hospital DC-ECV. Patients are included after giving
written informed consent. The study is designed as a pilot, open-label,
non-controlled, non-randomised, single centre study. The RACE-6 pilot study is
a prospective observational study (nurse-led home-based DC-ECV) which will be
carried out in the Netherlands by two well-trained emergency care practitioners
(ECPs), certified as sedatie anesthesiemedewerker voor cardioversies (SAMC) of
the ambulance service Ambulance Oost. The study is initiated and coordinated by
Ambulance Oost, Hengelo, the Netherlands. Patients will be followed for 6 weeks
for MACCE, costs and rhythm outcome.
Intervention
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 well known intervention
(standard electrical cardioversion) in a new (non-standard) environment, i.e.
at home.
Study burden and risks
The burden and risks are taken care of adequately and are well balanced by the
benefits and future treatment possibilities for atrial fibrillation.
Home cardioversion is a novel procedure. On one hand a reduction of the burden
for the patient from management is foreseen since the new treatment is
performed at the patient's home where all precautions are taken which are also
active in the hospital. Only stable patients who previously underwent the same
procedure uneventfully in the hospital will be selected. All precautions and
selections will prevent any complication but if such event happens, all
measures can and will be taken which would also have been taken in the
hospital. If needed the treatment can be taken over swiftly and adequately by
the hospital.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42344.068.12 |
| Other | NTR TC=4078 |
| OMON | NL-OMON26484 |