Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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.

More Atrial Fibrillation trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorOttawa Heart Institute Research Corporation
Academic / other
Locations2 sites (Newmarket, Ontario and 1 other locations)
StatusRecruiting
StartedFebruary 10, 2023
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedJuly 1, 2026
Trial IDNCT05136131 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.