Preventing Atrial Fibrillation Recurrence with Risk Factor Control
Reversal of Atrial Substrate to Prevent Atrial Fibrillation
This study is testing if managing health issues like high blood pressure and obesity along with a heart procedure can help people with atrial fibrillation avoid having it come back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 670 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 17 sites (Calgary, Alberta and 16 other locations) |
| Trial ID | NCT03682991 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of aggressive risk factor management combined with catheter ablation in preventing the recurrence of atrial fibrillation (AF). It is a multi-center, randomized trial that compares two approaches: standard catheter ablation versus catheter ablation plus intensive risk factor modification. The study aims to determine if addressing underlying risk factors such as hypertension, obesity, and diabetes can enhance the outcomes for patients with symptomatic AF. Participants will be monitored for AF recurrence following the interventions.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic paroxysmal or persistent atrial fibrillation who have at least two risk factors such as hypertension, obesity, or diabetes.
Not a fit: Patients with permanent atrial fibrillation or those who have previously undergone catheter ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of atrial fibrillation and improve the quality of life for affected patients.
How similar studies have performed: Previous studies have shown promise in managing atrial fibrillation through risk factor modification, suggesting that this combined approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with symptomatic (CCS-SAF ≥2) paroxysmal or persistent atrial fibrillation despite rate control, desiring catheter ablation and at least two of the following: * BMI ≥ 27, * BP ≥140/90 mmHg or history of hypertension, * Prior stroke/transient ischemic attack, * Diabetes, * Heart failure (prior heart failure admission or left ventricle ejection fraction (LVEF) \<40%), * Age ≥ 65 years * Current smoker * Excessive Alcohol use Exclusion Criteria: * Permanent AF (AF lasting \> 3 years) * Prior catheter ablation for AF * New York Heart Association (NYHA) Class IV (Severe) 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 16 other locations
- Foothills Hospital — Calgary, Alberta, Canada (Recruiting)
- Mazankowski Alberta Heart Institute — Edmonton, Alberta, Canada (Recruiting)
- Kelowna General Health — Kelowna, British Columbia, Canada (Recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Active_not_recruiting)
- Saint John Regional Hospital — Saint John, New Brunswick, Canada (Recruiting)
- QE II Health Sciences Centre — Halifax, Nova Scotia, Canada (Recruiting)
- Hamilton Health Sciences Center — Hamilton, Ontario, Canada (Recruiting)
- St. Mary's General Hospital — Kitchener, Ontario, Canada (Recruiting)
- London Health Sciences Center — London, Ontario, Canada (Recruiting)
- Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- Laval Hospital — Laval, Quebec, Canada (Completed)
- McGill University Health Centre — Montreal, Quebec, Canada (Active_not_recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
- Sacre Coeur Hospital — Montreal, Quebec, Canada (Recruiting)
- Regina General Hospital — Regina, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Ratika Parkash — Nova Scotia Health Authority
- Study coordinator: Ratika Parkash, MD FRCPC
- Email: Ratika.Parkash@nshealth.ca
- Phone: 902-474-4474
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.