PARTNER II Trial: Placement of AoRTic TraNscathetER Valves Trial

Title: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves Trial

Study Sponsor: Edwards Lifesciences, LLC

Principal Investigators: Dr. Wes Pedersen, Interventional Cardiologist & Dr. Vibhu Kshettry, Thoracic Surgeon

Study Synopsis:

This trial will evaluate the safety and effectiveness of the study device (not approved for sale in the US) called the Edwards SAPIEN XT tissue valve.  This valve is placed within the Aortic Valve through a procedure called transcatheter aortic valve implantation (TAVI).  In this procedure the physician threads a long tube (catheter) with a balloon and a heart valve attached to it through a blood vessel in your leg.  The heart valve is made of animal tissue.  Once the catheter is correctly placed inside the heart valve (aortic valve), the balloon is inflated, and the valve is released from the tube and anchored into place.  The long tube or catheter is then removed. 

Study Status: Currently enrolling

How do I qualify? 

Patients who have been told by their doctor that the opening in their aortic heart valve is too narrow (stenosis) may qualify to be in this study.  Patients may also be having symptoms such as shortness of breath, extreme tiredness or fatigue, or chest pain, which adversely affect their quality of life. In addition, they may have been told they are at high-risk for standard open heart valve surgery. 

Who do I contact for more information?  Sara Olson, 612-863-7601 or Peg Demmer,  612-863-6066.