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Search / Trial NCT05136131

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

Quality Of Life Improvement Electrical Cardioversion Sham Cardioversion Rhythm Control Placebo

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.

Locations

Ottawa, Ontario, Canada

Ottawa, Ontario, Canada

Patients applied

0 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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