Acute Atrial Fibrillation and Flutter Treated Electively

Atrial Fibrillation Clinical Trial

— AFFELECT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04267159
• Other study ID #: ETL R19133
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: June 2029

Study information

• Verified date: November 2023
• Source: Tampere University
• Contact: Jussi A Hernesniemi, MD, PhD
• Phone: 31164254
• Email: jussi.hernesniemi[@]sydansairaala.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2029
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Other:
• Acute cardioversion
Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department
• Delayed cardioversion
Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic

Locations

Country	Name	City	State
Finland	Kanta-Häme Central Hospital	Hämeenlinna	Kanta-Häme
Finland	Central Finland Central Hospital	Jyväskylä	Central Finland
Finland	Päijät-Häme Central Hospital	Lahti	Päijät-Häme
Finland	Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinus Rhythm	Prevalence of sinus rhythm in the treatment arms measured by electrocardiography	One month after preplanned out-patient clinic visit
Secondary	Number of cardioversions after emergency department	The number of performed cardioversions (electrical or medical)	First week after randomization and before the preplanned out-patient clinic
Secondary	Number of cardioversions after out-patient clinic	The number of performed cardioversions (electrical or medical)	One month after out-patient clinic
Secondary	Overall number of cardioversions	The number of performed cardioversions (electrical or medical)	From randomization to the end of first month follow-up after out-patient clinic visit
Secondary	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).	Four days or earlier after randomization to elective (delayed) treatment group
Secondary	Rehospitalization due to cardiovascular causes	Rehospitalization due to any cardiovascular cause	One week before and one month after out-patient clinic visit
Secondary	Immediate quality of life	Quality of life as assessed by questionnaires depicting quality of life (AFEQT)	First week after randomization and before the preplanned out-patient clinic
Secondary	Quality of life after out-patient clinic	Quality of life as assessed by questionnaires depicting quality of life (AFEQT)	One month after out-patient clinic