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Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement - ENVISION

Status: Recruiting

This study evaluates the safety and effectiveness of the Navitor TAVI system in patients with severe aortic valve narrowing who are at low or moderate surgical risk, aiming to expand its approval. It also includes patients needing valve-in-valve procedures(high surgical risk) for failing artificial valves and those with bicuspid aortic valves to better understand outcomes in these groups.

I'm interested

Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Moderate to severe symptoms from their heart condition that affect daily activities
• Severe narrowing of the aortic valve caused by age-related wear and tear
• Bicuspid Valve Cohort - Aortic valve with two flaps instead of three
• Valve-in-Valve Cohort - high or greater risk for open-heart surgery
Exclusion Criteria:
People may not be able to join the study if they have untreated heart artery blockages, recent heart procedures, very low blood counts, bleeding problems, infections, serious kidney disease, serious liver disease, serious lung disease, or cannot receive blood transfusions.
Interventions:

Drug/Device: The Navitor TAVI System

Conditions:

Adults with serious aortic stenosis who are low to moderate for open heart surgery with either a native aortic valve or bicuspid aortic valve. Adults with severe aortic stenosis that are high risk and have their previous artificial aortic valve no longer working properly.

Keywords:

Navitor TAVI system, Severe Aortic Valve Stenosis, Transcatheter Valve Replacement

Contact(s): Sureja Sundaralingam - ssundar4@hfhs.org
Principal Investigator: Tiberio Frisoli
Principal Investigator ID: tfrisol1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov

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