An interventional study of Acute cardioversion and Delayed cardioversion in Atrial Fibrillation and Atrial Flutter, sponsored by Tampere University. Recruiting at 4 sites in Finland. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Tampere University · Not applicable, Interventional, and Treatment
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 500 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Tampere University is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the conventional treatment arm will be returned to sinus rhythm in the emergency department within 48 hours of symptom onset unless they convert to sinus rhythm spontaneously.
Other: Acute cardioversion
Participants in the elective treatment arm will be returned to sinus rhythm in an out-patient clinic approximately one week after randomizatio unless they convert to sinus rhythm spontaneously.
Other: Delayed cardioversion
Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department
Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic
Sinus Rhythm
Prevalence of sinus rhythm in the treatment arms measured by electrocardiography
Time frame: One month after preplanned out-patient clinic visit
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
Number of cardioversions after out-patient clinic
The number of performed cardioversions (electrical or medical)
Time frame: One month after out-patient clinic
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
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
Rehospitalization due to cardiovascular causes
Rehospitalization due to any cardiovascular cause
Time frame: One week before and one month after out-patient clinic visit
Immediate quality of life
Quality of life as assessed by questionnaires depicting quality of life (AFEQT)
Time frame: First week after randomization and before the preplanned out-patient clinic
Quality of life after out-patient clinic
Quality of life as assessed by questionnaires depicting quality of life (AFEQT)
Time frame: One month after out-patient clinic
Plan to share: No — IPD can be shared only upon reasonable request after full anonymization by the discretion of the study review board.
Started Feb 2020 (actual). Primary completion is estimated for Jun 2027, 88 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 88 months is above that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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Tampere University