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).

‘Acute Cardioversion versus Wait And See-approach for symptomatic atrial fibrillation in the emergency department (ACWAS-trial)’

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23118

Enrollment

437

Registered

2014-07-02

Start date

2014-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation, irregular heartbeat, electrical cardioversion, pharmacological cardioversion. Boezemfibrilleren, atriumfibrilleren, onregelmatige hartslag, elektrische cardioversie, farmacologische cardioversie.

Interventions

A wait and see-approach, consisting of rate control drugs. Within 48 hours, patients will report to the outpatient clinic to check for spontaneous conversion to sinus rhythm.

Eligibility

Inclusion criteria

Inclusion criteria: - ECG with atrial fibrillation at the emergency department - Heart rate > 70bpm - Symptoms most probable due to atrial fibrillation - Duration of symptoms 18 years of age - Able and willing to sign informed consent - Able and willing to use MyDiagnostick

Exclusion criteria

Exclusion criteria: - Signs of myocardial infarction on ECG - Hemodynamic instability (systolic blood pressure 170 bpm) - Presence of pre-excitation syndrome - History of Sick Sinus Syndrome - History of unexplained syncope - Acute heart failure - Deemed unsuitable for participation by attending physician

Design outcomes

Primary

Measure	Time frame
Percentage of patients in sinus rhythm on 12-lead ECG at 4 weeks after index visit.	—

Secondary

Measure	Time frame
- Variance in outcome parameter associated with gender, time of presentation - Time to recurrence of AF (MyDiagnostick 4 weeks, hospital records 1 year) - AF-burden during 4 weeks following index visit (MyDiagnostick) - Number of recurrent paroxysms during 1 year - Total number of adverse events associated with primary visit - Hospitalization for stroke/TIA, emboli, bleeding, myocardial infarction, PCI/CABG and other arrhythmias during follow up - All-cause mortality - Biomarkers, DNA-analysis and ECG parameters - Safety assessment - Prediction of spontaneous conversion - Prediction of AF-recurrence - Correlation AF progression - Quality of Life - Total health care consumption - Total health care expenditure - Total societal costs	—

Measure

Time frame

- Variance in outcome parameter associated with gender, time of presentation - Time to recurrence of AF (MyDiagnostick 4 weeks, hospital records 1 year) - AF-burden during 4 weeks following index visit (MyDiagnostick) - Number of recurrent paroxysms during 1 year - Total number of adverse events associated with primary visit - Hospitalization for stroke/TIA, emboli, bleeding, myocardial infarction, PCI/CABG and other arrhythmias during follow up - All-cause mortality - Biomarkers, DNA-analysis and ECG parameters - Safety assessment - Prediction of spontaneous conversion - Prediction of AF-recurrence - Correlation AF progression - Quality of Life - Total health care consumption - Total health care expenditure - Total societal costs

—

Contacts

Public ContactE.A.M.P. Dudink

Maastricht University Medical Center, department of Cardiology P. Debyelaan 25

elton.dudink@mumc.nl+31433875119

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)