Improving quality of life for patients with persistent atrial fibrillation
Quality of Life Improvement After Cardioversion of Persistent AF - A Randomized Sham-Controlled Clinical Trial
This study is testing if a procedure to restore normal heart rhythm can help improve the quality of life for people with persistent atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 2 sites (Newmarket, Ontario and 1 other locations) |
| Trial ID | NCT05136131 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of electrical cardioversion on the quality of life in patients with persistent atrial fibrillation (AF). Participants will undergo a 4-week pre-cardioversion phase for medical optimization, including anticoagulation and rate-control medications. They will then be randomized to receive either actual cardioversion or a sham procedure, with outcomes assessed through questionnaires and activity monitoring. The aim is to determine if restoring normal heart rhythm can alleviate symptoms associated with AF.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with persistent atrial fibrillation and unknown symptom burden related to their condition.
Not a fit: Patients with known left-atrial appendage thrombus or those who have previously undergone catheter or surgical ablation for AF may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for patients suffering from persistent atrial fibrillation.
How similar studies have performed: Previous studies have shown mixed results regarding the benefits of rhythm control versus rate control in atrial fibrillation, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newmarket, Ontario and 1 other locations
- Southlake Health — Newmarket, Ontario, Canada (Recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: David Birnie, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Tammy Knight
- Email: tknight@ottawaheart.ca
- Phone: 613-696-7000
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.