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Acute Atrial Fibrillation and Flutter Treated Electively

RecruitingNAAges any - anyAllTampere University
NCT04267159 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The AFFELECT -study compares two types of treatment modalities for acute atrial fibrillation or flutter for patients in whom rhythm control is desirable. The main purpose is to observe if these arrhythmias can be safely treated electively (within 5-9 days). All patients are recruited in the emergency department. Patients must be in good clinical condition so that they can be discharged regardless to which treatment modality is randomly selected to them. Patients randomized to conventional care are treated conventionally which means acute rhythm control is applied by electrical or medical cardioversion in the emergency department (within 48 hours of onset of the arrhythmia). Patients randomized to elective care are discharged immediately after adequate temporary rhythm control is assured. All patients will visit a cardiologist out-patient clinic at approximately one week after the emerg

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients presenting with acute (\<48hours) atrial fibrillation or atrial flutter to ER * Planned acute rhythm control for the arrhythmia by the attending physician in ER * Good perceived health as assessed by attending physician in ER * Resting heart rate 110bpm or lower before or after adequate rate control therapy Exclusion Criteria: * Haemodynamically stable (mean arterial pressure above 60mmHg) * Need for acute restoration of sinus rhythm due to some other somatic cause * No other major complicating acute illness (e.g. decompensated HF or acute MI) * Anticoagulation not safe * Mechanical heart valve or mitral stenosis * The need for prolonged (\>24h) hospitalization due to any cause * Exceptionally high risk for thromboembolic events (e.g. history of thromboembolic stroke regardless of adequate anticoagulation) * Transesophageal echocardiography contraindicated
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What it tests

  • Acute cardioversion
  • Delayed cardioversion
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Where

4 sites
Central Finland Central Hospital
Jyväskylä, Finland
Kanta-Häme Central Hospital
Hämeenlinna, Finland
Päijät-Häme Central Hospital
Lahti, Finland
Tampere University Hospital
Tampere, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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