Clinical trial NCT04267159: Acute Atrial Fibrillation and Flutter Treated Electively
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Sinus Rhythm
timeFrame: One month after preplanned out-patient clinic visit
Secondary outcomes:
measure: Number of cardioversions after emergency department
timeFrame: First week after randomization and before the preplanned out-patient clinic
measure: Number of cardioversions after out-patient clinic
timeFrame: One month after out-patient clinic
measure: Overall number of cardioversions
timeFrame: From randomization to the end of first month follow-up after out-patient clinic visit
measure: Drop-out from delayed cardioversion group
timeFrame: Four days or earlier after randomization to elective (delayed) treatment group
measure: Rehospitalization due to cardiovascular causes
timeFrame: One week before and one month after out-patient clinic visit
measure: Immediate quality of life
timeFrame: First week after randomization and before the preplanned out-patient clinic
measure: Quality of life after out-patient clinic
timeFrame: One month after out-patient clinic
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
state: Central Finland
city: Hämeenlinna
country: Finland
facility: Kanta-Häme Central Hospital
state: Kanta-Häme
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
state: Päijät-Häme
Study officials:
affiliation: TAYS Heart Hospital and Tampere University
name: Jussi A Hernesniemi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: