Acute atrial fibrillation and flutter treated electively: rationale and design of the randomized controlled AFFELECT trial.
Jani Rankinen, Leo-Pekka Lyytikäinen, Juuso Järventie...
https://pubmed.ncbi.nlm.nih.gov/42064618Actively Recruiting
Phase Not Applicable
All Genders
ID04267159
Acute Atrial Fibrillation and Flutter Treated Electively - A Randomized Trial Comparing Immediate and Delayed Cardioversion for Safety
Led by Tampere University · Updated on 2026-05-22
500
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two treatment approaches for patients with acute atrial fibrillation or atrial flutter when rhythm control is desired. The study compares conventional acute cardioversion performed within 48 hours in the emergency department to elective delayed cardioversion performed approximately one week later in an out-patient clinic. The goal is to see if these arrhythmias can be safely managed with an elective timing approach. Participants are randomly assigned to either immediate cardioversion in the emergency department or to an elective delayed cardioversion after discharge. All patients receive anticoagulation treatment according to guidelines, with extra precautions such as transesophageal cardiac ultrasound if needed before delayed cardioversion. Patients in the elective group can choose early cardioversion if symptoms become unmanageable before the scheduled out-patient visit. Participants undergo follow-up visits including a cardiologist assessment about one week after enrollment and further assessments one month later with an ECG to check heart rhythm. Quality of life and symptom monitoring occur during the first week and one month after the clinic visit. Patients are then followed up for up to five years to monitor any medical interventions related to atrial fibrillation or flutter. New antiarrhythmic drugs like flecainide are not used during the first month.
CONDITIONS
Brief Title
Acute Atrial Fibrillation and Flutter Treated Electively
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patients presenting with acute (less than 48 hours) atrial fibrillation or atrial flutter to the emergency department
- Planned acute rhythm control for the arrhythmia by the attending physician in the emergency department
- Good perceived health as assessed by the attending physician in the emergency department
- Resting heart rate 110 beats per minute or lower before or after adequate rate control therapy
You will not qualify if you...
- Haemodynamically unstable (mean arterial pressure 60 mmHg or lower)
- Need for acute restoration of sinus rhythm due to another somatic cause
- Presence of major complicating acute illness such as decompensated heart failure or acute myocardial infarction
- Anticoagulation deemed unsafe
- Presence of mechanical heart valve or mitral stenosis
- Need for prolonged hospitalization over 24 hours for any reason
- Exceptionally high risk for thromboembolic events, such as history of thromboembolic stroke despite adequate anticoagulation
- Contraindication for transesophageal echocardiography
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 week after randomization
Participants receive either immediate cardioversion in the emergency department within 48 hours of symptom onset or delayed cardioversion approximately one week after randomization in an outpatient clinic.
1 emergency department visit and 1 outpatient clinic visit
Follow-up
Duration - Approximately 1 month after outpatient clinic visit
Participants are monitored for safety, quality of life, and rehospitalization up to one month after the outpatient clinic visit.
Follow-up assessments during 1 month after outpatient clinic visit
Trial Site Locations
Total: 4 locations
1
Central Finland Central Hospital
Jyväskylä, Central Finland, Finland
Actively Recruiting
2
Kanta-Häme Central Hospital
Hämeenlinna, Kanta-Häme, Finland
Actively Recruiting
3
Päijät-Häme Central Hospital
Lahti, Paijat-Hame Region, Finland
Not Yet Recruiting
4
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 03220
Actively Recruiting
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Research Team
J
Jussi A Hernesniemi, MD, PhD
T
Tero Penttilä, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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