Comparison between acute restoration of normal sinus rhythm and a wait-and-see-approach until spontaneous restoration of normal sinus rhythm in patients with acute symptomatic atrial fibrillation (ACWAS-trial).
- Conditions
- Atrial fibrillation, irregular heartbeat, electrical cardioversion, pharmacological cardioversion.Boezemfibrilleren, atriumfibrilleren, onregelmatige hartslag, elektrische cardioversie, farmacologische cardioversie.
- Registration Number
- NL-OMON23118
- Lead Sponsor
- Maastricht University Medical Center (MUMC+)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 437
Inclusion Criteria
ECG with atrial fibrillation at the emergency department
- Heart rate > 70bpm
Exclusion Criteria
- Signs of myocardial infarction on ECG
- Hemodynamic instability (systolic blood pressure < 100mmHg, heart rate > 170 bpm)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients in sinus rhythm on 12-lead ECG at 4 weeks after index visit.
- Secondary Outcome Measures
Name Time Method - Variance in outcome parameter associated with gender, time of presentation<br /><br>- Time to recurrence of AF (MyDiagnostick 4 weeks, hospital records 1 year)<br /><br>- AF-burden during 4 weeks following index visit (MyDiagnostick)<br /><br>- Number of recurrent paroxysms during 1 year<br /><br>- Total number of adverse events associated with primary visit<br /><br>- Hospitalization for stroke/TIA, emboli, bleeding, myocardial infarction, PCI/CABG and other arrhythmias during follow up<br /><br>- All-cause mortality<br /><br>- Biomarkers, DNA-analysis and ECG parameters<br /><br>- Safety assessment<br /><br>- Prediction of spontaneous conversion<br /><br>- Prediction of AF-recurrence<br /><br>- Correlation AF progression<br /><br>- Quality of Life <br /><br>- Total health care consumption<br /><br>- Total health care expenditure<br /><br>- Total societal costs <br>