Summary

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

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 Constriction, Pathologic 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 accepting new patients
    Sacramento California 95817 United States
  • Kaiser San Francisco Medical Center accepting new patients
    San Francisco California 94115 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT03042104
Study Type
Interventional
Last Updated