Improving quality of life for patients with persistent atrial fibrillation
Official title: Quality of Life Improvement After Cardioversion of Persistent AF - A Randomized Sham-Controlled Clinical Trial
Run by Ottawa Heart Institute Research Corporation · NCT05136131 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 2 sites (Newmarket, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | February 10, 2023 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT05136131 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with persistent atrial fibrillation and unknown symptom burden related to their condition.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.