Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial

Are you eligible to participate in this study?

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

  • Conditions:
    Aortic (valve) Stenosis
  • Age: Between 64 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are 65 years of age or older
    2. Subjects must have Severe Aortic Stenosis
    3. Subjects are asymptomatic defined as having negative treadmill stress test or as per physician after thorough assessment of patient history if the patient is unable to perform a stress test.
    4. Subjects have LV ejection fraction ≥50%
    5. Subjects have Society of Thoracic Surgeons (STS) risk score ≤10
    6. Subjects have been informed of the nature of the study, agrees to its provisions and has provided written informed consent

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

    1. Subjects are symptomatic (e.g., NYHA Functional Class =2, history of syncopal episode, or CCS angina score >1, hospitalization for heart failure within the last 12 months).
    2. Subjects have any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.
    3. Subjects have Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV based on 3D imaging analysis
    4. Subjects have Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
    5. Subjects have Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak (PVL) post TAVR
    6. Subjects have evidence of an acute myocardial infarction =30 days before randomization
    7. Subjects have aortic valve is unicuspid, bicuspid with unfavorable features for TAVR (e.g., aneurysmal , Version 3.0
    8. Subjects with severe aortic regurgitation (>3+)
    9. Subjects whith severe mitral regurgitation (>3+) or =moderate mitral stenosis
    10. Subjects with pre-existing mechanical or bioprosthetic valve in any position.
    11. Subjects with symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
    12. Subjects with leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
    13. Subjects with hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
    14. Subjects with hypertrophic cardiomyopathy with obstruction
    15. Subjects have Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
    16. Subjects not able to tolerate or condition precluding treatment with anti-thrombotic therapy
    17. Subjects who had Stroke or transient ischemic attack (TIA) within 90 days of randomization
    18. Subjects have renal insufficiency
    19. Subjects have active bacterial endocarditis within 180 days of randomization
    20. Subjects with Severe lung disease
    21. Subjects with Severe pulmonary hypertension
    22. Subjects with Significant frailty as determined by the Heart Team
    23. Subjects with Significant abdominal or thoracic aortic disease
    24. Subjects have significant abdominal or thoracic aortic disease
    25. Subjects refuses blood products
    26. Subjects are BMI >50 kg/m2
    27. Subjects who have Estimated life expectancy <24 months
    28. Subjects who have absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
    29. Subjects who are Currently participating in an investigational drug or another device study.

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