Trial Search Results

PARTNER 3 Trial: 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 accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Intervention(s):

  • Procedure: Surgical aortic valve replacement (SAVR)
  • Device: SAPIEN 3 THV

Phase:

N/A

Eligibility


Inclusion Criteria:

   1. Severe, calcific aortic stenosis

   2. NYHA Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited
   exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with LVEF <50%

   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.

Exclusion Criteria:

   1. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV

   2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer
   sheath

   3. Evidence of an acute myocardial infarction ≤ 30 days before randomization

   4. Aortic valve is unicuspid, bicuspid, or non-calcified

   5. Severe aortic regurgitation (>3+)

   6. Severe mitral regurgitation (>3+) ≥ moderate stenosis

   7. Pre-existing mechanical or bioprosthetic valve in any position

   8. Complex coronary artery disease:

      1. Unprotected left main coronary artery

      2. Syntax score > 32

      3. Heart Team assessment that optimal revascularization cannot be performed

   9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
   stenosis within 30 days of randomization

10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy,
   or hypercoagulable states

11. Hemodynamic or respiratory instability requiring inotropic support, mechanical
   ventilation or mechanical heart assistance within 30 days of randomization

12. Hypertrophic cardiomyopathy with obstruction

13. Ventricular dysfunction with LVEF < 30%

14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

15. Inability to tolerate or condition precluding treatment with
   antithrombotic/anticoagulation therapy during or after the valve implant procedure

16. Stroke or transient ischemic attack within 90 days of randomization

17. Renal insufficiency and/or renal replacement therapy at the time of screening.

18. Active bacterial endocarditis within 180 days of randomization

19. Severe lung disease or currently on home oxygen

20. Severe pulmonary hypertension

21. History of cirrhosis or any active liver disease

22. Significant frailty as determined by the Heart Team

23. Significant abdominal or thoracic aortic disease that would preclude safe passage of
   the delivery system or cannulation and aortotomy for surgical AVR

24. Hostile chest or conditions or complications from prior surgery that would preclude
   safe reoperation

25. Patient refuses blood products

26. BMI > 50 kg/m2

27. Estimated life expectancy < 24 months

28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately
   treated with pre-medication

29. Immobility that would prevent completion of study procedures

30. Patient is not a candidate for both arms of the study

31. Currently participating in an investigational drug or another device study.

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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