The PROGRESS Trial: A Prospective Randomized Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Moderate Aortic Stenosis
  • Age: Between 65 Year(s) - 115 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants with moderate, calcific aortic stenosis (AS)
    2. Subject meets at least one of the following criteria
      • Valve-related symptoms
      • LVEF <60%
      • Diastolic dysfunction (= Grade 2)
      • Stroke volume index < 35 mL/m2
      • NT-Pro BNP > 3x normal
      • Elevated calcium score
    3. Able to provide written informed consent

You may not be eligible for this study if the following are true:

    1. Native aortic annulus size unsuitable for the THV
    2. Anatomical characteristics that would preclude safe placement of the introducer sheath or safe passage of the delivery system
    3. Aortic valve is unicuspid or non-calcified
    4. Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
    5. Pre-existing mechanical or bioprosthetic aortic valve
    6. Severe aortic regurgitation
    7. Prior balloon aortic valvuloplasty (BAV) to treat severe AS
    8. LVEF <20%
    9. Left ventricular outflow tract (LVOT) calcification
    10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
    11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
    12. Hypertrophic cardiomyopathy with sub-valvular obstruction
    13. Any concomitant valvular disease requiring surgical or transcatheter intervention
    14. Significant untreated coronary artery disease requiring revascularization
    15. Severe chronic obstructive pulmonary disease or currently on home oxygen
    16. Liver disease
    17. Renal insufficiency and/or renal replacement therapy
    18. Significant frailty
    19. Leukopenia, anemia, thrombocytopenia
    20. Inability to tolerate or condition precluding treatment with antithrombotic therapy
    21. Hypercoagulable state or other condition that increases risk of thrombosis
    22. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
    23. Subject refuses blood products
    24. Body mass index (BMI) > 50 kg/m2
    25. Estimated life expectancy < 24 months
    26. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
    27. Participating in another drug or device study that has not reached its primary endpoint
    28. Subject considered to be part of a vulnerable population

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.