Actively Recruiting

Age: 18Years +
All Genders
NCT06249269

Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study

Led by Ratika Parkash · Updated on 2025-12-02

198

Participants Needed

7

Research Sites

147 weeks

Total Duration

On this page

Sponsors

R

Ratika Parkash

Lead Sponsor

N

Nova Scotia Health Research Fund

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic atrial fibrillation with a CCS-SAF score of 2 or higher
  • Paroxysmal or persistent atrial fibrillation despite rate control
  • Desire for catheter ablation
  • Body mass index (BMI) of 30 or higher, or at least two of the following: BMI over 27, blood pressure over 140/90 mmHg or history of hypertension, diabetes, heart failure (prior admission or ejection fraction below 40%), age 65 years or older, prior stroke or transient ischemic attack, current smoker, or excessive alcohol use (women: 10+ drinks/week or more than 2 drinks/day; men: 15+ drinks/week or more than 3 drinks/day)
  • Declined or were not approached for participation in the main study
  • Received catheter ablation for atrial fibrillation between November 1, 2019 and December 31, 2025
Not Eligible

You will not qualify if you...

  • Permanent atrial fibrillation lasting more than 3 years
  • Prior catheter ablation for atrial fibrillation
  • New York Heart Association Class IV heart failure
  • Participation in a cardiac rehabilitation program within the last year
  • Currently performing more than 150 minutes per week of moderate to vigorous exercise
  • Unable to exercise
  • Unable to give informed consent
  • Other non-cardiovascular medical condition likely to limit survival to less than 1 year
  • Younger than 18 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Foothills Hospital

Calgary, Alberta, Canada

Actively Recruiting

2

QEIIHSC

Halifax, Nova Scotia, Canada, B3H 3A7

Actively Recruiting

3

London Health Sciences Centre

London, Ontario, Canada

Actively Recruiting

4

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Actively Recruiting

5

Sunnybrook Hospital

Toronto, Ontario, Canada

Actively Recruiting

6

Montreal Heart Institute

Montreal, Quebec, Canada

Actively Recruiting

7

Regina General Hospital

Regina, Saskatchewan, Canada

Actively Recruiting

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Research Team

L

Laura Hamilton, BSC, MAHSR

CONTACT

K

Karen Giddens

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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