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Evolut™ EXPAND TAVR II Pivotal Trial

Recruiting
65 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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

Study details

Moderate Aortic Valve Stenosis

NCT05149755

Medtronic Cardiovascular

26 June 2024

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