Understanding Atrial Fibrillation Outcomes in Patients Who Decline Participation in a Clinical Trial

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.