Evolut™ EXPAND TAVR II Pivotal Trial

NCT05149755•Medtronic Cardiovascular

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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
+15 more criteria

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

Locations (94)

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 D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

University of Florida

Gainesville, Florida, United States

Key Dates

Start Date

April 27, 2022

Primary Completion Date

September 1, 2027

Completion Date

December 1, 2034

Last Updated

March 17, 2026

Enrollment

650

ESTIMATED participants

Conditions

Moderate Aortic Valve Stenosis

Interventions

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

DEVICE