Gurpreet S. Sandhu, M.D., Ph.D.

Closed for Enrollment

• REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation (REPRISE III) Rochester, Minn.

  The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

• Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) (SURTAVI) Rochester, Minn.

  The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

• Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial (RADIANT) Rochester, Minn.

  The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.