Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• symptomatic AF (CCS-SAF ≥2),
• paroxysmal or persistent atrial fibrillation despite rate control, desiring catheter ablation and either: i) BMI ≥ 30 or, ii) at least two of the following: BMI>27, BP>140/90 mmHg or history of hypertension, Diabetes, Heart failure (prior heart failure admission or LVEF<40%), Age ≥ 65 years, Prior stroke/TIA, Current smoker, Excessive alcohol use {For women: 10 or more drinks/week, more than 2 drinks a day (most days). For men: 15 or more drinks/week, more than 3 drinks a day (most days)}, and iii) declined or were not approached for participation in the main study. Eligible patients must have received catheter ablation for AF during the same timeline of the RASTA-AF Mian Study (November 1st, 2019 to December 31st, 2025).

🚫 You may not be able to join if…

• permanent AF (AF lasting > 3 years),
• prior catheter ablation for AF
• New York Heart Association Class IV heart failure
• participation in a cardiac rehabilitation program within the last year,
• currently performing exercise training >150 minutes/week of moderate to vigorous physical activity,
• unable to exercise,
• unable to give informed consent,
• other noncardiovascular medical condition making 1 year survival unlikely
• less than 18 years of age

Where this trial is running

• 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

Who to contact

Laura Hamilton, BSC, MAHSR · 902 473-7226 · laura.hamilton@nshealth.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06249269.