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Acute Atrial Fibrillation and Flutter Treated Electively (AFFELECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267159
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jussi Hernesniemi, Tampere University

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Other: Acute cardioversion Other: Delayed cardioversion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Immediate quality of life [ Time Frame: First week after randomization and before the preplanned out-patient clinic ]
    Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)

  2. Quality of life after out-patient clinic [ Time Frame: One month after out-patient clinic ]
    Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)

  3. 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)

  4. Number of cardioversions after out-patient clinic [ Time Frame: One month after out-patient clinic ]
    The number of performed cardioversions (electrical or medical)

  5. 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)

  6. 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).

  7. Rehospitalization due to cardiovascular causes [ Time Frame: One week before and one month after out-patient clinic visit ]
    Rehospitalization due to any cardiovascular cause



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267159


Contacts
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Contact: Jussi A Hernesniemi, MD, PhD 31164254 ext +358 jussi.hernesniemi@sydansairaala.fi
Contact: Tero Penttilä, MD, PhD

Locations
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Finland
Central Finland Central Hospital Not yet recruiting
Jyväskylä, Central Finland, Finland
Contact: Ossi Hannula, MD       ossi.hannula@ksshp.fi   
Kanta-Häme Central Hospital Not yet recruiting
Hämeenlinna, Kanta-Häme, Finland
Contact: Ari Palomäki, MD, PhD         
Tampere University Hospital Recruiting
Tampere, Pirkanmaa, Finland, 03220
Contact: Jussi A Hernesniemi, MD, PhD    31164254 ext +358    jussi.hernesniemi@sydansairaala.fi   
Päijät-Häme Central Hospital Not yet recruiting
Lahti, Päijät-Häme, Finland
Contact: Tuomo Nieminen, MD, PhD       tuomo.nieminen@phshp.fi   
Sponsors and Collaborators
Tampere University
Investigators
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Principal Investigator: Jussi A Hernesniemi, MD, PhD TAYS Heart Hospital and Tampere University

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Responsible Party: Jussi Hernesniemi, Adjunct Professor, Tampere University
ClinicalTrials.gov Identifier: NCT04267159    
Other Study ID Numbers: ETL R19133
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD can be shared only upon reasonable request after full anonymization by the discretion of the study review board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes