Acute Atrial Fibrillation and Flutter Treated Electively

NCT04267159 | Recruiting DMC

• 1 other identifier: ETL R19133
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• Sinus Rhythm

  Prevalence of sinus rhythm in the treatment arms measured by electrocardiography

  One month after preplanned out-patient clinic visit

Secondary Outcomes (7)

• Number of cardioversions after emergency department

  First week after randomization and before the preplanned out-patient clinic

• Number of cardioversions after out-patient clinic

  One month after out-patient clinic

• Overall number of cardioversions

  From randomization to the end of first month follow-up after out-patient clinic visit

• Drop-out from delayed cardioversion group

  Four days or earlier after randomization to elective (delayed) treatment group

• Rehospitalization due to cardiovascular causes

  One week before and one month after out-patient clinic visit

Study Arms (2)

Conventional treatment by acute cardioversion

ACTIVE COMPARATOR

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

Elective treatment by delayed cardioversion

EXPERIMENTAL

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

Interventions

Acute cardioversion OTHER

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

Conventional treatment by acute cardioversion

Delayed cardioversion OTHER

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

Elective treatment by delayed cardioversion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University: lead

Study Sites (4)

Central Finland Central Hospital

Jyväskylä, Central Finland, Finland

RECRUITING

Kanta-Häme Central Hospital

Hämeenlinna, Kanta-Häme, Finland

RECRUITING

Päijät-Häme Central Hospital

Lahti, Paijat-Hame Region, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, 03220, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 42064618 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jussi A Hernesniemi, MD, PhD

  TAYS Heart Hospital and Tampere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi A Hernesniemi, MD, PhD

CONTACT

31164254; jussi.hernesniemi@sydansairaala.fi

Tero Penttilä, MD, PhD

CONTACT

tero.penttila@sydansairaala.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: February 10, 2020
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (4)