HVP_Mitral Valve in Valve Edwards
HVP MViV A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Key Inclusion Criteria:
1. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
2. Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
3. NYHA Functional Class ≥ II.
4. Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥ 3 and < 8). The Heart Team evaluation should include risk calculators such as the STS as well as overall clinical status and comorbidities not fully addressed by the STS risk score (verified during the case review process).
5. Heart Team agrees valve implantation will likely benefit the patient.
**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