Comparing treatments for acute atrial fibrillation and flutter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Central Finland Central Hospital
  Jyväskylä, Central Finland, Finland Recruiting
• Kanta-Häme Central Hospital
  Hämeenlinna, Kanta-Häme, Finland Recruiting
• Tampere University Hospital
  Tampere, Pirkanmaa, Finland Recruiting
• Päijät-Häme Central Hospital
  Lahti, Paijat-Hame Region, Finland Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.