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NCT Number: NCT04267159

Acute Atrial Fibrillation and Flutter Treated Electively

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Finland Central Hospital, Jyväskylä, Central Finland, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute cardioversion

Other

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

Delayed cardioversion

Other

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

Primary outcomes

  1. Sinus Rhythm

    Time frame: One month after preplanned out-patient clinic visit

    Prevalence of sinus rhythm in the treatment arms measured by electrocardiography

Secondary outcomes

  1. 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)

  2. Number of cardioversions after out-patient clinic

    Time frame: One month after out-patient clinic

    The number of performed cardioversions (electrical or medical)

  3. 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)

  4. 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).

  5. Rehospitalization due to cardiovascular causes

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

    Rehospitalization due to any cardiovascular cause

  6. Immediate quality of life

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

    Quality of life as assessed by questionnaires depicting quality of life (AFEQT)

  7. Quality of life after out-patient clinic

    Time frame: One month after out-patient clinic

    Quality of life as assessed by questionnaires depicting quality of life (AFEQT)

Study contacts

Contact information is provided by the study sponsor or research team.

Jussi A Hernesniemi, MD, PhD

CONTACT

[email protected]

31164254 ext. +358

Tero Penttilä, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Registry information

Official study 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

Acronym: AFFELECT

Important dates

Study start
2020
Primary completion
2027
Study completion
2029
First posted
Feb 12, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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