Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
Recruiting · NCT06249269 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ratika Parkash
View the official record on ClinicalTrials.gov →What this trial 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 take part
Inclusion criteria
- 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).
Exclusion criteria
- 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 it is running
7 locations listed.
- 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