The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).
- Aortic Stenosis
- Eligible Ages
- Over 19 Years
- Eligible Genders
- Accepts Healthy Volunteers
- No age restriction.
- Severe, calcific aortic stenosis.
- Heart team agrees the patient has a risk of operative mortality and has an STS <4.
- 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)/Ethics Committee (EC) of the respective clinical site.
- Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
- Severe aortic regurgitation (>3+).
- Severe mitral regurgitation (>3+).
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Surgical aortic valve replacement (SAVR)
Edwards SAPIEN 3 THV
- Active, not recruiting
- Edwards Lifesciences
Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.
A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.