To evaluate a new valve, the Portico™ NG Transcatheter Aortic Heart Valve, in patients who have symptomatic, severe aortic stenosis and are determined to be at high or extreme surgical risk.
Aortic valve stenosis
To be considered for this study you must meet the following criteria:
- 18 years of age or older
- Have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
- Have symptomatic, severe aortic stenosis as demonstrated by NYHA Functional Classification of II, III or IV
Your participation in this study would be for approximately 5 years.
You will need to undergo a minimally invasive surgical procedure to have the valve inserted and stay in hospital overnight. You will then be seen in the clinic at 30 days, 12 months and then annually thereafter up to 5 years post-procedure. During these visits you will be asked about your health, medications, have a physical examination, 6-minute walk test, blood test, an ultrasound of your heart and ECG performed.