RASTA-Cohort: Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study.
RASTA-Cohort
Lead PI & Sponsor
Pablo B. Nery, David Birnie, Atul Verma, George Wells (University of Ottawa)
Local PI
Dr. Allan Skanes
Research Staff
Trinity Papamandjaris
Objective
The purpose of this study is to help the RASTA-AF RCT investigators better understand how effective risk factor modification might be for people like yourself who have AF and have chosen to undergo catheter ablation but do not want to take part in the RASTA-AF trial or have already had an AF ablation (within the past 2 years). Randomized control trials are the best way to determine if an intervention is effective, however, it is well known that patients decline participation in clinical trials for many reasons, and that there are often differences between the people who agree to participate in a trial and those who do not.
Target Number of Patients
50
Currently Enrolled
5
Primary Outcomes
- AF related hospitalizations and ER visits
- AF > 24hr duration after 5 months post randomization
Secondary Outcomes
- A composite of AF-related hospitalizations and ED visits or clinically significant AF (≥24 hours with symptoms) post randomization
- Stroke/Systemic Embolism
- Quality of Life
- GENESIS PRAXY Gender Questionnaire (66)
- Recurrent AF ablations
- Cardioversions after 2 months post ablation
- Major bleeding
- Death
Inclusion Criteria
- (a) BMI ≥ 30 OR (b) 2 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
Exclusion Criteria
- Permanent AF (> 3 years)
- Prior catheter ablation for AF
- NYHA 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
The objective of RASTA-Cohort is to answer the following question: do 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 do they suffer from worse AF-related outcomes than patients in the RCT, as compared to the control arm and intervention arm?