Patient Specific Ablation Strategy for Atrial Fibrillation (AWARE-2): A Randomized Clinical Trial

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Mar 26, 2021

Keywords

ClinConnect Summary

The AWARE-2 clinical trial is studying a new approach to treat Atrial Fibrillation (AF), a heart rhythm problem that affects many people and can lead to serious health issues like strokes and heart failure. This trial aims to compare a standard treatment method called catheter ablation with a new, personalized method that takes into account each person's unique health factors. Researchers believe that this tailored approach could lead to better results and fewer instances of AF returning after treatment.

To be eligible for the trial, participants should be at least 18 years old and have experienced at least two episodes of AF in the past year. They must also be able to give informed consent. Participants will be randomly assigned to either the standard treatment or the new personalized method. Throughout the trial, they will be monitored to assess the effectiveness and safety of the treatments, particularly focusing on results in women. If you or someone you know is interested, it's important to check with a healthcare provider to see if they meet the eligibility criteria and to discuss any questions about the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years on the date of consent for the trial.
• • 2. Subjects must have Paroxysmal AF with at least two episodes of AF over the past 12 months; Early Persistent AF- at least two episodes of AF.
• • 3. At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans- telephonic monitor (TTM) or Loop Recorder.
• • 4. Subjects must be able to provide informed consent.
• Exclusion Criteria:
• • 1. Persistent and permanent AF
• • 2. History of previous catheter or surgical ablation for AF, AFl, AT, AVNRT, AVRT.
• • 3. Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial.
• • 4. Previous left atrial (LA) ablation or LA surgery.
• • 5. Previous pulmonary vein stenosis or pulmonary vein stent.
• • 6. Pre-existing hemi-diaphragmatic paralysis.
• • 7. Active intracardiac thrombus.
• • 8. Contraindication to systemic oral anticoagulation therapy or radiocontrast materials.
• • 9. Current immunosuppressant therapy (corticosteroids, biologic immunomodulators; such patients may be considered if they can safely discontinue immunosuppressants for three months prior to and for three months following catheter ablation).
• • 10. Reversible causes of AF (eg. uncontrolled hyperthyroidism, within six months of cardiac surgery).
• • 11. Left ventricular ejection fraction \<35%.
• • 12. NYHA Class 3-4 heart failure.
• • 13. Hypertrophic cardiomyopathy with septal or posterior LV wall thickness of \>1.8 cm.
• • 14. Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation).
• • 15. Known adverse reaction to adenosine.
• • 16. Significant chronic kidney disease (eGFR \<30ml/min/1.73m2).
• • 17. Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, subjects with patent foramen ovale will not be excluded).
• • 18. Pregnant subjects.
• • 19. Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial.
• • 20. Life expectancy less than one-year.
• • 21. Currently participating or anticipated to participate in clinical trials of drug, device or biologic agents that could affect the results of this trial.
• • 22. Unwilling or unable to comply fully with study procedures and follow-up.