3 results
Approved WMOWill not start
The purpose of this study is to assess the safety and performance of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transapical Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
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,…
Approved WMOCompleted
To obtain user and medical staff feed-back on the safety, clinical performance and ergonomic features of the IPS and IBO.