Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Official Title

Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

Details

This is a prospective, randomized, controlled, multicenter study. Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Keywords

Heart Diseases, Aortic Stenosis, Severe, Aortic valve, Asymptomatic, Transcatheter aortic valve replacement, Aortic Valve Stenosis, Pathologic Constriction, Edwards SAPIEN 3 / SAPIEN 3 Ultra THV, TAVR

Eligibility

You can join if…

Open to people ages 65 years and up

  1. 65 years of age or older
  2. Severe aortic stenosis
  3. Patient is asymptomatic
  4. LV ejection fraction ≥ 50%
  5. Society of Thoracic Surgeons (STS) risk score ≤ 10
  6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You CAN'T join if...

  1. Patient is symptomatic
  2. Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.
  3. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV
  4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
  5. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR
  6. Evidence of an acute myocardial infarction ≤ 30 days before randomization
  7. Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified
  8. Severe aortic regurgitation (>3+)
  9. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis

    10. Pre-existing mechanical or bioprosthetic valve in any position 11. Symptomatic carotid or vertebral artery disease or successful treatment of carotid

    stenosis within 30 days of randomization

    12. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy,

    or hypercoagulable states

    13. Hemodynamic or respiratory instability requiring inotropic support, mechanical

    ventilation or mechanical heart assistance within 30 days of randomization

    14. Hypertrophic cardiomyopathy with obstruction 15. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 16. Inability to tolerate or condition precluding treatment with anti-thrombotic therapy 17. Stroke or transient ischemic attack within 90 days of randomization 18. Renal insufficiency and/or renal replacement therapy 19. Active bacterial endocarditis within 180 days of randomization 20. Severe lung disease or currently on home oxygen 21. Severe pulmonary hypertension 22. History of cirrhosis or any active liver disease 23. Significant frailty as determined by the Heart Team 24. Significant abdominal or thoracic aortic disease that would preclude safe passage of

    the delivery system

    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. Currently participating in an investigational drug or another device study. 30. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with

    COVID-19 with sequelae that could confound endpoint assessments

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • Kaiser San Francisco Medical Center
    San Francisco California 94115 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach California 92663 United States
  • Mills Peninsula Health Services
    Burlingame California 94010 United States
  • Huntington Hospital
    Pasadena California 91105 United States
  • Stanford Hospital and Clinics Palo Alto
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT03042104
Study Type
Interventional
Participants
About 901 people participating
Last Updated