Acute Atrial Fibrillation and Flutter Treated Electively
Launched by TAMPERE UNIVERSITY · Feb 10, 2020
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The AFFELECT study is a clinical trial that is looking at two different ways to treat patients with acute atrial fibrillation or flutter, which are conditions where the heart beats irregularly. The goal of the trial is to see if these heart problems can be safely managed on an elective basis, meaning treatment can happen within a few days after the initial emergency visit. Patients who are feeling well enough and meet certain criteria can participate in this study. They are typically those who have been in the emergency department for less than 48 hours and have a resting heart rate of 110 beats per minute or lower.
If you join the study, you will be randomly assigned to one of two treatment groups. One group will receive immediate treatment in the emergency department, while the other group will be discharged with a plan to follow up with a cardiologist within a week. If someone in the second group is still experiencing issues, they will receive the necessary treatment at that follow-up appointment. Throughout the study, participants will be monitored for their health and any symptoms, and they will fill out questionnaires to help assess their quality of life. It’s important to know that all participants will receive blood-thinning medication to reduce the risk of blood clots, and there will be ongoing monitoring for up to five years after the trial's conclusion.
Gender
ALL
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
About Tampere University
Tampere University, a leading research institution in Finland, is dedicated to advancing scientific knowledge and innovation through rigorous clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its expertise in health sciences, engineering, and social sciences to conduct impactful research that addresses pressing health challenges. Tampere University is committed to ethical research practices and fostering partnerships with healthcare providers and industry stakeholders to translate findings into meaningful clinical applications, ultimately enhancing patient care and public health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hämeenlinna, , Finland
Lahti, , Finland
Jyväskylä, Central Finland, Finland
Hämeenlinna, Kanta Häme, Finland
Tampere, Pirkanmaa, Finland
Lahti, Päijät Häme, Finland
Patients applied
Trial Officials
Jussi A Hernesniemi, MD, PhD
Principal Investigator
TAYS Heart Hospital and Tampere University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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