Evolut™ EXPAND TAVR II Pivotal Trial

Not Applicable

Recruiting

• Conditions: Moderate Aortic Valve Stenosis

• Registration Number: NCT05149755
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-08
• Study Start: 2022-04-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-02
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.	30 days	Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.	2 years

Secondary Outcome Measures

Name	Time	Method
Composite of all-cause mortality and heart failure hospitalizations or events.	2 years
Days alive and free of unplanned cardiovascular hospitalizations	2 years
Unplanned cardiovascular hospitalizations	2 years
Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)	1 year
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations	2 years
Heart failure hospitalizations or events.	2 years
All-cause mortality	2 years

Trial Locations

Locations (99)

University of Alabama at Birmingham (UAB) Hospital; 🇺🇸 Birmingham, Alabama, United States

Abrazo Arizone Heart Hospital; 🇺🇸 Phoenix, Arizona, United States

HonorHealth Scottsdale Shea Medical Center; 🇺🇸 Scottsdale, Arizona, United States

Los Robles Hospital & Medical Center; 🇺🇸 Thousand Oaks, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Saint Vincents Medical Center; 🇺🇸 Bridgeport, Connecticut, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

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