Understanding Atrial Fibrillation Outcomes in Patients Who Decline Participation in a Clinical Trial
Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
This study looks at the health and quality of life of people with atrial fibrillation who choose not to join a clinical trial to see how their outcomes compare to those who do participate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 198 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 7 sites (Calgary, Alberta and 6 other locations) |
| Trial ID | NCT06249269 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to investigate the clinical characteristics and quality of life of patients with symptomatic atrial fibrillation (AF) who choose not to participate in the RASTA-AF randomized control trial. By enrolling these patients, the study will compare their outcomes to those of participants in the RASTA-AF trial, focusing on the impact of aggressive risk factor management and catheter ablation. The research will provide insights into the differences in health outcomes between those who accept and decline participation in clinical trials, particularly in the context of an aging population in Nova Scotia. The findings could help inform future treatment strategies for AF.
Who should consider this trial
Good fit: Ideal candidates are individuals with symptomatic paroxysmal or persistent atrial fibrillation who have declined participation in the RASTA-AF trial.
Not a fit: Patients with permanent atrial fibrillation or those who have previously undergone catheter ablation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of atrial fibrillation management and better treatment strategies for patients who decline clinical trial participation.
How similar studies have performed: While this approach is novel in its focus on patients declining trial participation, similar studies have shown the importance of understanding non-participant outcomes in clinical research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta and 6 other locations
- Foothills Hospital — Calgary, Alberta, Canada (Recruiting)
- Qeiihsc — Halifax, Nova Scotia, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Hospital — Toronto, Ontario, Canada (Recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
- Regina General Hospital — Regina, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Ratika Parkash, MD, FRCPC — Nova Scotia Health
- Study coordinator: Laura Hamilton, BSC, MAHSR
- Email: laura.hamilton@nshealth.ca
- Phone: 902 473-7226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.