2 results
Approved WMOWill not start
Primary: To evaluate the safety of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.Secondary: To evaluate adverse events and study device performance.
Approved WMOCompleted
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…