Comparing treatments for acute atrial fibrillation and flutter
Acute Atrial Fibrillation and Flutter Treated Electively - a Randomized Controlled Clinical Trial on the Safety of Elective Management of Acute Atrial Fibrillation and Flutter
This study is testing two different ways to treat people with sudden atrial fibrillation or flutter in the emergency room to see if a less immediate approach can be done safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Tampere University Academic / other |
| Locations | 4 sites (Jyväskylä, Central Finland and 3 other locations) |
| Trial ID | NCT04267159 on ClinicalTrials.gov |
What this trial studies
The AFFELECT study evaluates two treatment approaches for patients with acute atrial fibrillation or flutter who require rhythm control. Patients presenting to the emergency department will be randomly assigned to either conventional care, which involves immediate cardioversion, or elective care, where they are discharged after temporary rhythm control is achieved. Follow-up visits with a cardiologist will occur approximately one week after the emergency room visit to assess the effectiveness of the treatment. The goal is to determine if elective treatment can be safely implemented within a short timeframe.
Who should consider this trial
Good fit: Ideal candidates include patients presenting with acute atrial fibrillation or flutter within 48 hours who are in good clinical condition.
Not a fit: Patients with hemodynamic instability or other major acute illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more efficient treatment option for patients with acute atrial fibrillation and flutter.
How similar studies have performed: While there have been studies on rhythm control in atrial fibrillation, this specific approach of elective treatment within a short timeframe is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jyväskylä, Central Finland and 3 other locations
- 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, Finland (Recruiting)
Study contacts
- Principal investigator: Jussi A Hernesniemi, MD, PhD — TAYS Heart Hospital and Tampere University
- Study coordinator: Jussi A Hernesniemi, MD, PhD
- Email: jussi.hernesniemi@sydansairaala.fi
- Phone: 31164254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.