NCT06249269Recruiting
Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 198 (estimated)
- First submitted
- 3 Jan 2024
- Start date
- 1 May 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Ratika Parkash
- Diseases
- Atrial fibrillation
- NCT number
- NCT06249269
What you commit to
- Study type: Observational
- Planned participants: 198
- From 1 May 2024 to the primary completion date, Dec 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior catheter ablation for AF
Other illness
- New York Heart Association Class IV heart failure
- participation in a cardiac rehabilitation program within the last year,
- other noncardiovascular medical condition making 1 year survival unlikely
Age
- permanent AF (AF lasting \> 3 years),
- less than 18 years of age
Other
- currently performing exercise training \>150 minutes/week of moderate to vigorous physical activity,
- unable to exercise,
- unable to give informed consent,
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Foothills Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| QEIIHSC Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Regina General Hospital Coordinator of this site? Confirm its status | Regina | Canada | Recruiting |
| Sunnybrook Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.