Study for adults with severe aortic stenosis.
The Safety and Effectiveness of the SAPIEN XT™ Transcatheter Heart Valve with NovaFlex and Ascendra delivery systems in Intermediate and High Risk for Aortic Valve Surgery and Patients Who Cannot Undergo Surgery and the SAPIEN 3 Transcatheter Heart Valve with Associated Delivery Systems in High Risk or Inoperable Patients with Severe Symptomatic Aortic Stenosis
Kron Irving, L
The Divisions of Cardiothoracic Surgery and Interventional Cardiology at UVA Health System are testing an experimental heart valve for use in adults who have severe narrowing of the aortic heart valve and who are at high risk for having traditional surgery to correct their condition or who are not able to have traditional surgery at all. The purpose of the study is to test the Edwards SAPIEN XT Transcatheter Heart Valve, an artificial device made to replace a diseased aortic heart valve. The experimental valve is placed through a catheter going through blood vessels and does not require open-heart surgery. The study involves regular visits to UVA for follow up over about 5 years and includes echocardiograms, neurologic exams, blood tests, x-rays, and questionnaires about quality of life. Participants will be paid up to $700 for finishing this study ($100 after each of the seven required follow up visits which are completed at the University of Virginia). Contact Information: For more information please contact: • Study nurse coordinators in the Surgical Therapeutic Advancement Center • Office: 434-243-0315 • Email: firstname.lastname@example.org • IRB-HSR # 15514 Principal Investigator: Irving L. Kron, MD
Thoracic & Cardiovascular Surgery
Heart Valve Diseases
Heart Failure (Congestive Heart Failure)
Chest Pain (Angina)