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EXPAND II

  • Status
    Accepting Candidates
  • Age
    65 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Description

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.

Details

Full study title Evolut EXPAND TAVR II Pivotal Trial
Protocol number OCR43345
ClinicalTrials.gov ID NCT05149755
Phase N/A

Eligibility

Key Inclusion Criteria:

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

  • AVA >1.0 cm虏 and 0.6cm虏/m虏 if BMI < 30 kg/m虏: or

  • AVA 鈮� 1.0 cm虏 with AVAI > 0.5cm虏/m虏 if BMI 鈮� 30 kg/m虏:

and

  • Max aortic velocity 鈮� 3.0 m/sec. and < 4.0 m/sec. or

  • Mean aortic gradient 鈮� 20mmHg and < 40.0 mmHg

Any of the following at-risk features:

  • Symptoms of AS, defined as:

  • NYHA 鈮� 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 鈮� 600 pg/ml (or BNP 鈮� 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 鈮�16% (absolute value), or

    • E/e' 鈮� 14.0 (average of medial and lateral velocities), or

    • Diastolic dysfunction 鈮� Grade II, or

    • LVEF < 60%

    • Stroke Volume Index < 35 ml/m虏

  • 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 鈮� 20% by 2-D echo

  • Class I indication for cardiac surgery

  • Contraindication for placement of a bioprosthetic valve

  • Documented history of cardiac amyloidosis

Lead researcher

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