Acute Atrial Fibrillation and Flutter Treated Electively (AFFELECT)
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|ClinicalTrials.gov Identifier: NCT04267159|
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Flutter||Other: Acute cardioversion Other: Delayed cardioversion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The AFFECT trial is a randomized clinical trial with a non-inferioirity setting studying the applicability of delayed rhythm control in the management of acute paroxysmal or persistent atrial fibrillation or flutter.
Patients are randomized to two treatment protocols in 2:3 ratio. For every two patients randomized to conventional treatment, three patients are randomized to experimental treatment. The randomization ratio is designed to allow for maximally one third of the patients in the experimental treatment group to drop-out without compromising the power of the study.
Overall five hundred patients are required to show non-inferiority with a one-sided alpha value 0.025 and 90% power expecting a maximal drop out rate of 33% (n=100) from the experimental treatment arm.
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Acute Atrial Fibrillation and Flutter Treated Electively - A Randomized Controlled Clinical Trial on the Safety of Elective Management of Acute Atrial Fibrillation and Flutter|
|Actual Study Start Date :||February 10, 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2026|
Active Comparator: Conventional treatment by acute cardioversion
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
Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department
Experimental: Elective treatment by delayed 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
Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic
- Sinus Rhythm [ Time Frame: One month after preplanned out-patient clinic visit ]Prevalence of sinus rhythm in the treatment arms measured by electrocardiography
- Immediate quality of life [ Time Frame: First week after randomization and before the preplanned out-patient clinic ]Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)
- Quality of life after out-patient clinic [ Time Frame: One month after out-patient clinic ]Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)
- Number of cardioversions after emergency department [ Time Frame: First week after randomization and before the preplanned out-patient clinic ]The number of performed cardioversions (electrical or medical)
- Number of cardioversions after out-patient clinic [ Time Frame: One month after out-patient clinic ]The number of performed cardioversions (electrical or medical)
- Overall number of cardioversions [ Time Frame: From randomization to the end of first month follow-up after out-patient clinic visit ]The number of performed cardioversions (electrical or medical)
- Drop-out from delayed cardioversion group [ Time Frame: Four days or earlier after randomization to elective (delayed) treatment 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).
- Rehospitalization due to cardiovascular causes [ Time Frame: One week before and one month after out-patient clinic visit ]Rehospitalization due to any cardiovascular cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267159
|Contact: Jussi A Hernesniemi, MD, PhD||31164254 ext +email@example.com|
|Contact: Tero Penttilä, MD, PhD|
|Central Finland Central Hospital||Not yet recruiting|
|Jyväskylä, Central Finland, Finland|
|Contact: Ossi Hannula, MD firstname.lastname@example.org|
|Kanta-Häme Central Hospital||Not yet recruiting|
|Hämeenlinna, Kanta-Häme, Finland|
|Contact: Ari Palomäki, MD, PhD|
|Tampere University Hospital||Recruiting|
|Tampere, Pirkanmaa, Finland, 03220|
|Contact: Jussi A Hernesniemi, MD, PhD 31164254 ext +358 email@example.com|
|Päijät-Häme Central Hospital||Not yet recruiting|
|Lahti, Päijät-Häme, Finland|
|Contact: Tuomo Nieminen, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Jussi A Hernesniemi, MD, PhD||TAYS Heart Hospital and Tampere University|