To evaluate a new mitral valve replacement in patients who moderate-severe or severe mitral regurgitation at a high surgical risk.
To be considered for the study you must meet the following criteria:
- Aged 18 years or older
- Moderate-severe or severe mitral regurgitation
- Unable to undertake open heart surgery
Your participation in this study would be for approximately 5 years.
You will need to attend a pre-screening period which consists of a CT scan, 6 min walk test, a blood test and ultrasound of your heart. If eligible, you will need to undergo a procedure to have a valve inserted and stay in hospital for up to 2-3 days. You will then be followed up post procedure, 7 days after discharge, at 1, 3 ,6, 12 months and then annually up to 5 years. During these visits you will be asked about your health and medications and have a physical examination, blood test, echocardiogram and ECG.
You will be reimbursed for travel and study related expenses.