Acute Atrial Fibrillation and Flutter Treated Electively (AFFELECT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Other: Acute cardioversion; Other: Delayed cardioversion

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jussi A Hernesniemi, MD, PhD; Phone Number: +358 31164254; Email: jussi.hernesniemi@sydansairaala.fi
• Study Contact Backup: Name: Tero Penttilä, MD, PhD; Email: tero.penttila@sydansairaala.fi

Study Locations

• Finland
  • Central Finland
    • Jyväskylä, Central Finland, Finland
      • Recruiting
      • Central Finland Central Hospital
      • Contact: Tuomo Kyrönlahti, MD; Email: tuomo.kyronlahti@ksshp.fi
  • Kanta-Häme
    • Hämeenlinna, Kanta-Häme, Finland
      • Recruiting
      • Kanta-Häme Central Hospital
      • Contact: Ari Palomäki, MD, PhD
  • Paijat-Hame Region
    • Lahti, Paijat-Hame Region, Finland
      • Not yet recruiting
      • Päijät-Häme Central Hospital
      • Contact: Tuomo Nieminen, MD, PhD; Email: tuomo.nieminen@phshp.fi
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 03220
      • Recruiting
      • Tampere University Hospital
      • Contact: Jussi A Hernesniemi, MD, PhD; Phone Number: +358 41732 2932; Email: jussi.hernesniemi@sydansairaala.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sinus Rhythm	Prevalence of sinus rhythm in the treatment arms measured by electrocardiography	One month after preplanned out-patient clinic visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of cardioversions after out-patient clinic	The number of performed cardioversions (electrical or medical)	One month after out-patient clinic
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
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
Rehospitalization due to cardiovascular causes	Rehospitalization due to any cardiovascular cause	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)	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)	One month after out-patient clinic

Collaborators and Investigators

• Sponsor: Tampere University
• Investigators: Principal Investigator: Jussi A Hernesniemi, MD, PhD, TAYS Heart Hospital and Tampere University

Publications and helpful links

General Publications

• Rankinen J, Lyytikainen LP, Jarventie J, Hautamaki M, Numminen A, Hurskainen M, Rantanen M, Muuronen A, Tynkkynen J, Hernesniemi J. Acute atrial fibrillation and flutter treated electively: rationale and design of the randomized controlled AFFELECT trial. Eur Heart J Open. 2026 Apr 13;6(2):oeag060. doi: 10.1093/ehjopen/oeag060. eCollection 2026 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: ETL R19133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD can be shared only upon reasonable request after full anonymization by the discretion of the study review board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No