Objective
The purpose of this study, called a randomized control trial, is to find out if patients with risk factors for AF will benefit from a treatment strategy that combines risk factor modification with catheter ablation, versus catheter ablation only...
Background
In this trial we want to find out if aggressive management of risk factors is useful for people with your type of heart rhythm problem. This study involves managing risk factors associated with AF such as: high blood pressure (hypertension), diabetes, obesity, tobacco use, alcohol intake and sleep apnea (difficulties with breathing during sleep) before your ablation procedure, and whether this strategy could prevent your abnormal heart rhythm from returning after the procedure.
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
- Individual components of the primary outcome
- Mean burden of AF measured from 2 months post-ablation to the end of follow-up as recorded by ICM
- Stroke / systemic embolism
- Quality of life
- Health outcome
- 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-AF Letter of Information