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  • Status
    Accepting Candidates
  • Age
    65 Years - N/A
  • Sexes
  • Healthy Volunteers


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


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.


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


Key Inclusion Criteria:

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


  • AVA >1.0 cm² and < 1.5 cm² and

  • Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, OR mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg, • 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) • Any of the following

  • HF event or hospitalization for heart failure within 1 calendar year prior to consent

  • NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml),

  • 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)

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

  • Diastolic dysfunction ≥ Grade II

  • LVEF < 60%

  • Stroke Volume Index < 35 ml/m²

  • Anatomically suitable for transfemoral RAVR 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

  • Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm

  • Not anatomically suitable for transfemoral TAVR with the trial device

  • In need of and suitable for coronary revascularization per Heart Valve Team

  • Documented history of cardiac amyloidosis

Lead researcher

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  1. Step

    Contact the research team

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    Primary contact

  2. Step

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  3. Step

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  4. Step


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