In this prospective interventional feasibility study, we would like to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Atrial fibrillation (AF) is common daily practice in hospitals and when not
treated it is associated with significant morbidity and mortality. Its economic
burden is high in affluent countries. Direct current electrical cardioversion
(DC-ECV) is one of the methods to restore patients' sinus rhythm, which is
usually done in an emergency (cardiac) room or Coronary care unit. Nowadays,
rapid service is difficult to achieve in many institutions due to logistical
problems surrounding DC-ECV (shortage of beds, limited number of staff,
problematic INR monitoring and staff workload).
The Dutch government is trying to achieve a shift in the treatment of patients
from the inpatient services to outpatient services. The emphasis is on
treatments that do not necessarily have to take place in the hospital. This
shift, to the primary setting (i.e., general practitioners of medical emergency
care practitioners) is supposed to reduce costs while maintaining a high
quality of care. Moreover, (medical) care is increasingly focused on the needs
and wishes of the patient with diagnostics, triage and possibly treatment close
to the patient's home environment.
Since January 2019, advanced practice providers (APP), working at Emergency
medical service (EMS) RAV Brabant MWN perform "procedural sedation and
analgesia"(PSA), the sedation is applied to enable short, very painful
procedures or to reduce agitation. This offers an opportunity to organize a
DC-ECV outside the hospital.
Study objective
In this prospective interventional feasibility study, we would like to assess
the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF
performed by APP in 25 patients.
Study design
This study is designed as a pilot, non-controlled, non-randomised, single
centre study. The Electra-1 pilot study is a prospective intervention
feasibility study.
Intervention
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 certified advanced practice providers
(APP) on site, i.e. nurse practitioner or physician assistant, supported by an
EMS ambulance team containing an ambulance nurse and ambulance driver, both
trained advanced life-support (ALS) professionals.
Study burden and risks
The study is designed to reduce the burden of DC-ECV by treating patients in
their own environment.
Home DC-ECV is an intervention that is performed in exactly the same way as in
the clinical setting; the performers are, however, not a medical specialist,
but well trained and qualified APP*s and ambulance professionals.
By various precautions, such as targeted education/training of the APP*s,
telephonic back-up from medical specialists and presence of ambulance
professionals, the risk of home DC-ECV is minimized.
Henri Dunantstraat 1
's-Hertogenbosch 5223GZ
NL
Henri Dunantstraat 1
's-Hertogenbosch 5223GZ
NL
Listed location countries
Age
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 < 35 kg/m2
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%, or cor pulmonale * transient and
reversible cause of AF, e.g. in setting of fever and hyperthyroidism 4.
Patients with severe co-morbidities: a. liver disease b. kidney impairment
(eGFR <= 30 according to formula MDRD) c. pulmonary dysfunction (FEV1 /VC <75%
gold classification) d. active malignancy e. connective tissue disease f.
inflammatory disease such as peri-myocarditis/endocarditis 5. Life expectancy
less than 1 year 6. Patients with ventricular tachycardia or supraventricular
arrhythmias 7. Patients with slow ventricular rate (< 55/min), bifascicular
block 8. Contraindications to a sedation 9. Patients lacking family care at
home 10. Pregnancy 11. ASA 3 & 4 12. BMI > 35 kg/m2
Design
Recruitment
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 | NL83536.028.23 |