Study ID: PORTICO
PORTICO: A trial for patients with severe aortic stenosis who are at high risk for needing open-heart aortic valve replacement
Patients with aortic stenosis who are candidates for heart valve replacement but are at high surgical risk for open-heart valve replacement may be eligible to participate in the PORTICO trial. The goal of the trial is to test the safety and effectiveness of the Portico transcatheter aortic valve system as compared to a commercially available one.
The Portico system enables the surgeon to resheath the valve within the catheter during valve deployment, which allows for greater precision when positioning the new valve.
The Portico re-sheathable transcatheter aortic valve system US IDE trial (PORTICO) is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico transcatheter heart valve and delivery systems (Portico) via transfemoral and alternative delivery methods. The study analyzes the high-risk and extreme-risk cohorts together against a commercially available control for primary safety and effectiveness endpoints. Such endpoints include all-cause mortality, stroke and aortic insufficiency/regurgitation. Study patients are followed for a total of five years.
- Must have aortic stenosis
- Must be considered by the heart team as high risk for open-heart surgery
- Must have symptoms of aortic stenosis
- Must agree to attend all follow-up appointments for a period of five years after the procedure
Additional criteria may apply.