Evolut™ EXPAND TAVR II Pivotal Trial

Covidien

Status: Enrolling

Conditions: Moderate Aortic Valve Stenosis

Treatments: Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05149755

D00411092

Details and patient eligibility

About

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

Full 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.

Enrollment: 650 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

o 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)

Experimental group

Description:

Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, \& guideline-directed management \& therapy

Treatment:

Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)

Clinical site determined guideline-directed management and therapy (GDMT) alone

No Intervention group

Description:

Clinical site determined guideline-directed management and therapy (GDMT) alone