2 results
Not approvedWill not start
To evaluate the safety and effectiveness of the ATS 3f Enable* Aortic Bioprosthesis equine pericardial stented bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures.
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,…