Acute Atrial Fibrillation and Flutter Treated Electively

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorTampere University

About this trial

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 emergency room visit. Patients randomized to elective treatment and still in atrial fibrillation or in atrial flutter will be restored to sinus rhythm by electrical or medical cardioversion at the out-patient clinic. Cardiovascular status and treatment options are evaluated for all patients.

Anticoagulation is managed according existing guidelines for all patients. Due to possibility of delayed cardioversion in the interventional group (elective care group), all patients receive anticoagulation before the out-patient clinic despite their thromboembolic risk. All patients who have not received adequate anticoagulation for three weeks prior to the delayed cardioversion will undergo a transesophageal cardiac ultrasound to ensure they are not in excess risk for thromboembolic events. Patients randomized to elective treatment have the possibility to opt-out and undergo acute cardioversion if their symptoms are unmanageable during the first week before the out-patient clinical.

All patients are monitored for their symptoms by a standardized quality-of-life questionnaire and for possibly required acute medical interventions during the first week and one month after the out-patient clinic. After one month, all patients undergo an electrocardiography (ECG) to ensure the maintenance of normal rhythm in both treatment groups. After the months follow-up all patients are subsequently monitored for a maximum of five years for need of medical interventions due to atrial fibrillation of atrial flutter. New antiarrhythmics such as flecainide are not prescribed during the first month.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acute cardioversion

    Other intervention

    Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department

  • Delayed cardioversion

    Other intervention

    Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Conventional treatment by acute cardioversionActive comparator 1 intervention
Group B: Elective treatment by delayed cardioversionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sinus Rhythm

Prevalence of sinus rhythm in the treatment arms measured by electrocardiography

Time frame
One month after preplanned out-patient clinic visit

Secondary outcomes

1

Number of cardioversions after emergency department

The number of performed cardioversions (electrical or medical)

Time frame
First week after randomization and before the preplanned out-patient clinic
2

Number of cardioversions after out-patient clinic

The number of performed cardioversions (electrical or medical)

Time frame
One month after out-patient clinic
3

Overall number of cardioversions

The number of performed cardioversions (electrical or medical)

Time frame
From randomization to the end of first month follow-up after out-patient clinic visit
4

Drop-out from delayed cardioversion group

The number of subjects needing unplanned cardioversion before preplanned out-patient clinic visit (four days or earlier after randomization) due to medical reasons or due to subjectively perceived unbearable symptoms (EHRA III or IV).

Time frame
Four days or earlier after randomization to elective (delayed) treatment group

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.