Trial Search Results
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).
Stanford is currently not accepting patients for this trial.
- Procedure: Surgical aortic valve replacement (SAVR)
- Device: Transcatheter Aortic Valve Replacement (TAVR)
1. No age restriction.
2. Severe, calcific aortic stenosis.
3. Heart team agrees the patient has a risk of operative mortality and has an STS <4.
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.
1. Ilio-femoral vessel characteristics that would preclude safe placement of the
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is
4. Severe aortic regurgitation (>3+).
5. Severe mitral regurgitation (>3+).
Ages Eligible for Study
19 Years - N/A
Genders Eligible for Study