RecruitingNot ApplicableNCT04267159

Acute Atrial Fibrillation and Flutter Treated Electively

Acute Atrial Fibrillation and Flutter Treated Electively - a Randomized Controlled Clinical Trial on the Safety of Elective Management of Acute Atrial Fibrillation and Flutter


Sponsor

Tampere University

Enrollment

500 participants

Start Date

Feb 10, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for patients who come to the emergency room with recent-onset atrial fibrillation (irregular heartbeat lasting less than 48 hours): immediate treatment to restore normal rhythm in the ER versus a planned outpatient (elective) cardioversion later, to see which is safer and equally effective. **You may be eligible if:** - You presented to the emergency room with atrial fibrillation or atrial flutter that started within the past 48 hours - Your attending ER doctor plans to restore your normal heart rhythm acutely - Your heart rate is 110 bpm or lower before or after rate control treatment - Your overall health status is good as assessed by your doctor **You may NOT be eligible if:** - Your blood pressure is dangerously low (hemodynamically unstable) - You have a mechanical heart valve or mitral stenosis - You have another serious acute illness (like severe heart failure or heart attack) - Blood thinners (anticoagulation) are not safe for you - You have a very high risk of blood clots or stroke Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERAcute cardioversion

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

OTHERDelayed cardioversion

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


Locations(4)

Central Finland Central Hospital

Jyväskylä, Central Finland, Finland

Kanta-Häme Central Hospital

Hämeenlinna, Kanta-Häme, Finland

Päijät-Häme Central Hospital

Lahti, Paijat-Hame Region, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04267159


Related Trials