The Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial aims to test a new heart valve system called the Portico. This trial helps people with a condition called aortic stenosis, where their heart valve does not open fully, making it hard for blood to flow. The trial includes 750 patients who are at high risk for surgery. Participants will be randomly assigned to receive either the Portico valve or another approved valve. The trial will check safety after 30 days and effectiveness after one year.
- The study lasts for 5 years, with follow-ups at multiple times.
- Participants must be 21 or older and agree to follow-up visits.
- Risks include potential surgical complications, so participants must be high or extreme risk patients.
People who want to join must have severe symptoms and meet specific health criteria. They cannot join if they have certain heart conditions, recent heart attacks, or other severe health issues. This study ensures that only those who qualify and consent can participate, ensuring safety and reliability.