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 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.
Background
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?
Study Outcomes
Primary
- AF related hospitalizations and ER visits
- AF > 24hr duration after 5 months post randomization
Secondary
- 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
- Recurrent AF ablations
- Cardioversions after 2 months post ablation
- Major bleeding
- Death
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- (a) BMI ≥ 30 OR (b) two of the following risk factors:
- 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
About taking part
If you are considering joining this study, please review the Letter of Information below. It explains the study in detail, including what participation involves, the potential risks and benefits, and your rights as a participant.
RASTA-Cohort Letter of Information