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.

Lead Sponsor:

Edwards Lifesciences

Intervention(s):

  • Procedure: Surgical aortic valve replacement (SAVR)
  • Device: Transcatheter Aortic Valve Replacement (TAVR)

Phase:

N/A

Eligibility


Inclusion Criteria:

   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.

Exclusion Criteria:

   1. Ilio-femoral vessel characteristics that would preclude safe placement of the
   introducer sheath.

   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
   non-calcified.

   4. Severe aortic regurgitation (>3+).

   5. Severe mitral regurgitation (>3+).

Ages Eligible for Study

19 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting