No registrations found.
ID
Source
Brief title
Health condition
Atrium fibrillation
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of patients with complications related to the anaesthesia or the ECV procedure between 0-2 and 2-24 hours after the procedure.
Secondary outcome
The occurrence of stroke/ complications up to 30 days after the ECV procedure.
The type, severity, treatment, and outcomes of the reported complications.
Background summary
Electrical cardioversion (ECV) is an effective treatment for patients with AF, restoring sinus rhythm in approximately 90% of cases.The Amsterdam University Medical Center (Amsterdam UMC), location AMC, treats more than 500 patients with an elective ECV, per year. If the patients feel well enough, they are discharged to their home environment, under supervision for the first evening and night.
Research question
Is it safe for patients who have undergone an elective ECV in the AMC, to spend the first evening and night alone at home, without additional supervision?
For this retrospective outcome analysis, “safe” is defined as the absence of complications related to the anaesthesia or the cardioversion, in the first 24 hours after the ECV procedure.
Study objective
Is it safe for patients who have undergone an elective ECV in the AMC, to spend the first evening and night alone at home, without additional supervision?
Study design
Timepoint 1: Baseline measurements: cardiac rate, rhythm, and other cardiac variables, before ECV.
Timepoint 2: 0-2 hours after ECV: cardiac rate and rhythm, adverse events or complications, their type, severity, treatment, and outcome, measured until discharge from hospital.
Timepoint 3: 2-24 hours: any adverse events or complications as a result of the anesthesia or ECV, their type, severity, treatment, and outcome, measured from discharge until 24 hours after ECV.
Timepoint 4: 30 days: Any adverse events or complications as a result of the anesthesia or ECV, their type, severity, treatment, and outcome, measured between 24 hours and one month after the procedure.
Intervention
None, observational
Femke Piersma
020 566 3794
f.r.piersma@amsterdamumc.nl
Femke Piersma
020 566 3794
f.r.piersma@amsterdamumc.nl
Inclusion criteria
- Patients who underwent ECV in Amsterdam UMC, location AMC in 2019 and 2020
- Patients > 18 years
Exclusion criteria
- Patients who completed an objection to the re-use of care data.
Design
Recruitment
IPD sharing statement
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 |
---|---|
NTR-new | NL9433 |
Other | METC Amsterdam UMC, location AMC : W21_151#21.166, confirmed as non-WMO study |