Tests whether restoring normal heart rhythm improves quality of life in atrial fibrillation
Compares electrical cardioversion with a sham procedure in adults with persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: QOL Improvement After Cardioversion of Persistent AF (QOL-CAFRCT)
Key facts
- Where
- Newmarket and Ottawa, CanadaSee the 2 sites
Where in Canada
- Southlake HealthNewmarket, CanadaTaking people
- University of Ottawa Heart InstituteOttawa, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ottawa Heart Institute Research Corporation
- Trial code
- NCT05136131
- Record updated
- 1 July 2026
- Original description
Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden.Read full original descriptionShow less
Quality of Life Improvement After Cardioversion of Persistent AF - A Randomized Sham-Controlled Clinical Trial
Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden.
Rhythm control strategies in patients with persistent AF include cardioversion back to sinus rhythm with long-term recurrence prevention via anti-arrhythmic drugs (AADs) or catheter ablation. However, many studies of these procedures omit a sham placebo control arm. No atrial fibrillation procedural intervention has been compared to a sham procedure. The cardioversion procedure can easily be compared to a "sham" alternative, as it is non-invasive with an expected response within days-to-weeks. Thus, a cardioversion versus "sham" cardioversion trial will allow us to truly assess the impact of a rhythm-control strategy on QOL. It is hypothesized that cardioversion of atrial fibrillation leads to significant improvement in quality of life (QOL) compared to sham cardioversion.
Understanding the true QOL impact of sinus rhythm restoration in patients with persistent AF is of significant importance in guiding strategies for the management of AF. Hence, by evaluating what the true effect of cardioversion on QOL in this blinded study, we can better understand the role of medical management and AF ablation in our patients and assess resource allocation to these procedures.
Inclusion: Patients age ≥ 18 years; Persistent atrial fibrillation; Unknown symptom burden related to AF.
Exclusion: Prior catheter or surgical ablation for AF; Patient with a history of noncompliance with medical therapy; Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrolment); Known left-atrial appendage thrombus; 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 does not meet all of the above listed inclusion criteria; Breastfeeding; Patients for whom the investigator believes that the trial is not in the interest of the patient.