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 (propofol) 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) on site supported by well
trained and certified sedation practitioners from the Ziekenhuis Groep Twente.
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,
multicentre study. Eligible patients who attended the Coronary Care Unit (CCU)
of the participating hospitals in 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, multicentre 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 well-trained and Sedation-certified
emergency care practitioners (ECP's) of the ambulance service Ambulance Oost on
site supported by well trained and certified Sedation Practitioners. 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 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
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63041.068.17 |
| Other | NTR TC=4078 |