Evolut™ EXPAND TAVR II Pivotal Trial

NCT05149755 | Active Not Recruiting DMC FDA Device

• 1 other identifier: D00411092
• Study Type: interventional
• Target: 650
• Locations: 15 countries
• Sites: 92

Brief Summary

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

Conditions

Moderate Aortic Valve Stenosis

Keywords

aortic; stenosis; moderate; valve; TAVR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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 and heart failure hospitalizations or events.

  2 years

• 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

Study Arms (2)

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

EXPERIMENTAL

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)

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

NO INTERVENTION

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

Interventions

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

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).

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• MWT \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (94)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, 35233, United States

Location

Abrazo Arizone Heart Hospital

Phoenix, Arizona, 85016, United States

Location

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, 85260, United States

Location

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Saint Vincents Medical Center

Bridgeport, Connecticut, 06606-4201, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Saint Vincent's Medical Center Riverside

Jacksonville, Florida, 32204, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308-5054, United States

Location

Tampa General Hospital

Tampa, Florida, 33620, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, 48109-1274, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Englewood Hospital & Medical Center

Englewood, New Jersey, 076931, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Wake Forest University Heatlh Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-1716, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Kettering Health Main Campus

Kettering, Ohio, 45429, United States

Location

Oregon Health & Science University Hospital

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital, Inc

Allentown, Pennsylvania, 18103, United States

Location

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, 17101, United States

Location

Monument Health Rapid City Hospital

Rapid City, South Dakota, 57701, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

Texas Health Harris Methodist Hospital Fort Worth

Fort Worth, Texas, 76104, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Methodist Hospital San Antonio

San Antonio, Texas, 78229, United States

Location

Intermountain Cardiovascular and Thoracic Surgery

Salt Lake City, Utah, 84111, United States

Location

The University of Vermont

Burlington, Vermont, 05401-1473, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, 99204, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Aurora Saint Lukes Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

University Hospital Sankt Poelten

Sankt Pölten, Austria, 3100, Austria

Location

Allgemeines Krankenhaus - Universitätskliniken Wien

Vienna, 1030, Austria

Location

CHU de Liege- Hopital du Sart Tilman

Liège, 4000, Belgium

Location

London Health Sciences Centre- University Campus

London, Ontario, N6C 2R5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Montreal Heart Hospital

Montreal, Quebec, H1T1C8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, B3H 3A7, Canada

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, Brittany Region, France

Location

CHRU Brest - Hôpital de la Cavale Blanche

Brest, 29609, France

Location

Institut Médico-Chirurgical Montsouris

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitätsklinikum Bonn

Bonn, 53217, Germany

Location

Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund

Dortmund, 44137, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Klinikum der Universität München - Campus Grosshadern

München, 15, 81377, Germany

Location

Galway University Hospitals - University Hospital Galway (UHG)

Galway, H91 YR71, Ireland

Location

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102, Israel

Location

Rabin Medical Center- Beilinson Hospital

Petah Tikva, Israel, 49100, Israel

Location

Presidio Ospedaliero Gaspare Rodolico

Catania, 95123, Italy

Location

Ospedale San Raffaele - Milano

Milan, 20132, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

Shonan Kamakura General Hospital

Kanagawa, Kamakura, 247-8533, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Kawasaki Saiwai Hospital

Kawasaki, Kanagawa, 212-0014, Japan

Location

Osaka Keisatsu Hospital

Osaka, 543-0035, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Catharina Ziekenhuis

Eindhoven, Netherlands, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands, 3015, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

Location

Hospital Universitari Clínic de Barcelona

Barcelona, Spain, 08036, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47006, Spain

Location

Skanes Universitetssjukhus

Lund, 22185, Sweden

Location

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

Location

Saint Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Constriction, Pathologic; Lymphoma, Follicular

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Paul Sorajja, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

• Josep Rodes-Cabau, MD

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

• Stephan Windecker, Prof.

  Inselspital, Universitätsspital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: April 27, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2034
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); NL (4); FR (4); IT (3); DE (6); SE (1); IE (1); US (52); GB (1); AU (2); JP (5); ES (4); BE (1); CA (5); IL (2)