Aortic Valve Stenosis

Study title

PORTICO-NG

Speciality

Cardiology

Description

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 

Eligibility criteria

To be considered for the 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 

Study details

Your participation in this study would be for approximately 12 months.    

 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 and 12 months 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. 

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Further information

NCT04011722