RecruitingNCT06249269

Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study


Sponsor

Ratika Parkash

Enrollment

198 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Atrial fibrillation (AF) is a major health problem, with a prevalence of 0.4-1% of the population. It results in high healthcare costs and significant morbidity, especially for patients with severe symptoms. The RASTA-AF randomized control trial (RCT) is designed to answer the following question: does vigorous treatment of AF with aggressive risk factor management plus catheter ablation reduce AF-related outcomes as compared to catheter ablation plus usual care in patients with symptomatic AF and risk factors that promote AF. This study is a multicenter, prospective cohort study that will enrol patients who decline participation in the RASTA-AF RCT but agree to be followed in a registry. The objective of RASTA-Cohort is to determine whether patients who decline participation in the RASTA-AF RCT have different clinical characteristics and quality of life than patients who accept participation in the study, and whether they suffer from worse AF-related outcomes than patients in the RCT.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study follows patients with irregular heart rhythm (atrial fibrillation, or AF) who have additional risk factors like obesity, high blood pressure, or diabetes. Participants undergo ablation (a procedure to correct the heart's electrical signals) along with lifestyle or medical changes. The study tracks whether these combined approaches reduce AF over time. **You may be eligible if...** - You have symptomatic atrial fibrillation despite rate control medication - You have paroxysmal or persistent AF and want catheter ablation - You have a BMI of 30 or higher, OR have at least two risk factors such as obesity, high blood pressure, diabetes, heart failure, age 65+, prior stroke, smoking, or excess alcohol use - You received catheter ablation between November 2019 and December 2025 - You declined or were not offered enrollment in the main RASTA-AF study **You may NOT be eligible if...** - You do not have symptomatic AF - You did not undergo catheter ablation during the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(7)

Foothills Hospital

Calgary, Alberta, Canada

QEIIHSC

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Regina General Hospital

Regina, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

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NCT06249269


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