HVP 2015 08 AViV: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve. TAVR valve in valve only.
To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.
Key Inclusion Criteria:
1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
2. Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
3. NYHA Functional Class ≥ II.
4. Heart Team agrees valve implantation will likely benefit the patient.
5. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Heart and Vascular
Valvular Heart Disease,
Robert Hodson MD
- Providence St. Vincent Medical Center