QOL Improvement After Cardioversion of Persistent AF (QOL-CAFRCT)
Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Nov 25, 2021
Trial Information
Current as of September 07, 2025
Recruiting
Keywords
ClinConnect Summary
The QOL-CAFRCT trial is studying how a procedure called cardioversion can improve the quality of life for patients with persistent atrial fibrillation (AF), which is a type of irregular heartbeat. This trial aims to compare the real effects of cardioversion, which restores a normal heart rhythm, to a sham procedure that mimics it but doesn't actually change the heart's rhythm. By doing this, researchers hope to find out if patients really feel better after undergoing cardioversion, since many previous studies haven't included a sham control to accurately assess the benefits.
To participate in this trial, you must be at least 18 years old and have persistent atrial fibrillation, with unclear symptoms related to your condition. However, if you've had certain heart procedures before, or if you have specific medical issues that prevent safe treatment, you may not be eligible. If you join the study, you will receive either the cardioversion procedure or the sham procedure, and researchers will track how your quality of life changes afterward. This information will help doctors understand the best ways to manage AF and whether cardioversion is a beneficial option for patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients age ≥ 18 years
- • Persistent atrial fibrillation
- • Unknown symptom burden related to AF
- Exclusion Criteria:
- • Known left-atrial appendage thrombus
- • Prior catheter or surgical ablation for AF
- • Intolerance or contraindication to Amiodarone
- • Contraindication to appropriate anticoagulation
- • Patient is included in another randomized clinical trial
- • Patient is unable or unwilling to provide informed consent
- • Patient with a history of noncompliance with medical therapy
- • Patient does not meet all of the above listed inclusion criteria
- • Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrolment)
- • Breastfeeding
- • Patients for whom the investigator believes that the trial is not in the interest of the patient
About Ottawa Heart Institute Research Corporation
The Ottawa Heart Institute Research Corporation is a leading clinical research organization dedicated to advancing cardiovascular medicine through innovative research and clinical trials. Affiliated with the renowned University of Ottawa Heart Institute, the corporation focuses on conducting high-quality, ethically-driven studies that aim to improve patient outcomes and enhance understanding of heart-related diseases. With a commitment to collaboration and excellence, the organization engages multidisciplinary teams of researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective therapies and interventions for cardiovascular health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ottawa, Ontario, Canada
Ottawa, Ontario, Canada
Patients applied
Trial Officials
David Birnie, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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