Structural Heart - EXPAND

Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.

Criteria:
Key Inclusion Criteria:

    Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:

    • AVA >1.0 cm² and <1.5cm²; or
    • AVA ≤ 1.0 cm² with AVAI > 0.6cm²/m² if BMI < 30 kg/m²: or
    • AVA ≤ 1.0 cm² with AVAI > 0.5cm²/m² if BMI ≥ 30 kg/m²:

    and

    • Max aortic velocity ≥ 3.0 m/sec. and < 4.0 m/sec. or
    • Mean aortic gradient ≥ 20mmHg and < 40.0 mmHg

    Any of the following at-risk features:

    • Symptoms of AS, defined as:
    • NYHA ≥ Class II, or

    • Reduced functional capacity, defined as

      • 6MWT < 300 meters, or
      • < 85% of age-sex predicted METs on exercise tolerance testing (ETT)
    • Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
    • NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
    • Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
    • Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or

    • Any of the following by the qualifying TTE as assessed by the ECL:

      • Global longitudinal strain ≤16% (absolute value), or
      • E/e' ≥ 14.0 (average of medial and lateral velocities), or
      • Diastolic dysfunction ≥ Grade II, or
      • LVEF < 60%
      • Stroke Volume Index < 35 ml/m²
    • Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
    • The subject and the treating physician agree the subject will return for all required follow-up visits

    Key Exclusion Criteria:

    • Age < 65 years
    • LVEF ≤ 20% by 2-D echo
    • Class I indication for cardiac surgery
    • Contraindication for placement of a bioprosthetic valve
    • Documented history of cardiac amyloidosis

    Location: Hartford Hospital
    ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT05149755
    Sponsor: Medtronic
    Contact: Jadwiga Jerman 860-972-9146 Jadwiga.Jerman@hhchealth.org