The trial is taking place at:
C

Cardiovascular Research Institute of Kansas, LLC | Wichita, KS

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EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

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Edwards Lifesciences

Status

Active, not recruiting

Conditions

Aortic Stenosis, Severe
Heart Diseases

Treatments

Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV

Study type

Interventional

Funder types

Industry

Identifiers

NCT03042104
2016-07

Details and patient eligibility

About

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.

Full description

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.

Enrollment

901 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  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.

Exclusion criteria

  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

901 participants in 2 patient groups

TAVR
Experimental group
Description:
Transcatheter aortic valve replacement (TAVR)
Treatment:
Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
CS
No Intervention group
Description:
Clinical surveillance (CS)

Trial contacts and locations

77

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Data sourced from clinicaltrials.gov

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