Evolut™ EXPAND TAVR II Pivotal Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate Aortic Valve Stenosis
• Intervention / Treatment: Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)

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 Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Austria
  • Sankt Pölten, Austria, 3100
    • University Hospital Sankt Poelten
  • Vienna, Austria, 1030
    • Allgemeines Krankenhaus - Universitätskliniken Wien
• Belgium
  • Liège, Belgium, 4000
    • CHU de Liege- Hopital du Sart Tilman
• Canada
  • Halifax, Canada, B3H 3A7
    • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6C 2R5
      • London Health Sciences Centre- University Campus
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T1C8
      • Montreal Heart Hospital
    • Québec, Quebec, Canada, G1V 4G5
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
• France
  • Brest, France, 29609
    • CHRU Brest - Hôpital de la Cavale Blanche
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75014
    • Institut Médico-Chirurgical Montsouris
  • Brittany Region
    • Rennes, Brittany Region, France
      • CHU de Rennes - Hopital Pontchaillou
• Germany
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • Bonn, Germany, 53217
    • Universitatsklinikum Bonn
  • Dortmund, Germany, 44137
    • Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • München, Germany, 15, 81377
    • Klinikum der Universität München - Campus Grosshadern
• Ireland
  • Galway, Ireland, H91 YR71
    • Galway University Hospitals - University Hospital Galway (UHG)
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center- Beilinson Hospital
• Italy
  • Catania, Italy, 95123
    • Presidio Ospedaliero Gaspare Rodolico
  • Milan, Italy, 20132
    • Ospedale San Raffaele - Milano
  • San Donato Milanese, Italy, 20097
    • IRCCS Policlinico San Donato
• Japan
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Osaka, Japan, 543-0035
    • Osaka Keisatsu Hospital
  • Kamakura
    • Kanagawa, Kamakura, Japan, 247-8533
      • Shonan Kamakura General Hospital
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
    • Kawasaki, Kanagawa, Japan, 212-0014
      • Kawasaki Saiwai Hospital
• Netherlands
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Nieuwegein, Netherlands, 3435
    • St Antonius Ziekenhuis
  • Rotterdam, Netherlands, 3015
    • Erasmus MC
• Spain
  • Barcelona, Spain, 08036
    • Hospital Universitari Clínic de Barcelona
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Salamanca, Spain, 37007
    • Complejo Asistencial Universitario de Salamanca
  • Valladolid, Spain, 47006
    • Hospital Clinico Universitario de Valladolid
• Sweden
  • Lund, Sweden, 22185
    • Skanes universitetssjukhus
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital - Universitätsspital Bern
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Saint Bartholomew's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham (UAB) Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Abrazo Arizone Heart Hospital
    • Scottsdale, Arizona, United States, 85260
      • HonorHealth Scottsdale Shea Medical Center
  • California
    • Thousand Oaks, California, United States, 91360
      • Los Robles Hospital & Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606-4201
      • Saint Vincents Medical Center
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Gainesville, Florida, United States, 32608
      • University of Florida
    • Jacksonville, Florida, United States, 32204
      • Saint Vincent's Medical Center Riverside
    • Orlando, Florida, United States, 32806
      • Orlando Health
    • Tallahassee, Florida, United States, 32308-5054
      • Tallahassee Memorial Hospital
    • Tampa, Florida, United States, 33620
      • Tampa General Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Terrebonne General Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1274
      • University of Michigan Health System - University Hospital
    • Detroit, Michigan, United States, 48236
      • Ascension Saint John Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110
      • SSM Health Saint Louis University Hospital
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • Englewood, New Jersey, United States, 076931
      • Englewood Hospital & Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Heatlh Sciences
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106-1716
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
    • Kettering, Ohio, United States, 45429
      • Kettering Health Main Campus
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital, Inc
    • Harrisburg, Pennsylvania, United States, 17101
      • UPMC Pinnacle Harrisburg Campus
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Rapid City Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas
    • Fort Worth, Texas, United States, 76104
      • Texas Health Harris Methodist Hospital Fort Worth
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84111
      • Intermountain Cardiovascular and Thoracic Surgery
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • The University of Vermont
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center & Children's Hospital
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Lukes Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT); Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy	Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT); Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
No Intervention: Clinical site determined guideline-directed management and therapy (GDMT) alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.	30 days
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

Outcome Measure	Time Frame
All-cause mortality	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
Unplanned cardiovascular hospitalizations	2 years
Days alive and free of unplanned cardiovascular hospitalizations	2 years
Composite of all-cause mortality and heart failure hospitalizations or events.	2 years
Heart failure hospitalizations or events.	2 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Paul Sorajja, MD, Allina Health System; Principal Investigator: Josep Rodes-Cabau, MD, Fondation IUCPQ; Principal Investigator: Stephan Windecker, Prof., Inselspital, Universitätsspital Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: aortic; valve; stenosis; moderate; TAVR
• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Constriction, Pathologic; Lymphoma, Follicular; Therapeutics
• Other Study ID Numbers: D00411092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes