To evaluate a new valve in patients with moderate-severe or severe mitral regurgitation and at high surgical risk.
Heart failure due to mitral valve regurgitation
To be considered for this study you must meet the following criteria:
- 18 years of age or older
- Have moderate to severe mitral regurgitation
- Unable to undergo open heart surgery
Your participation in this study would be for approximately five years.
You will need to undergo a procedure to have the valve inserted and stay in hospital for up to 2-3 days. You will then be seen in the clinic at 30 days, 3 months, 6 months and 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, ultrasound of your heart and ECG.
You will be reimbursed for travel and study-related expenses.