Evolut™ EXPAND TAVR II Pivotal Trial

May 15, 2026 updated by: Medtronic Cardiovascular
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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 Europeén Georges Pompidou
      • Paris, France, 75014
        • Institut Médico-chirurgical Montsouris
    • Brittany Region
      • Rennes, Brittany Region, France
        • CHU De Rennes - Hôpital 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 Clínico Universitario de Valladolid
  • Sweden
      • Lund, Sweden, 22185
        • Skånes 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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.
30 days
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
All-cause mortality
Time Frame: 2 years
2 years
Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)
Time Frame: 1 year
1 year
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Time Frame: 2 years
2 years
Unplanned cardiovascular hospitalizations
Time Frame: 2 years
2 years
Days alive and free of unplanned cardiovascular hospitalizations
Time Frame: 2 years
2 years
Composite of all-cause mortality and heart failure hospitalizations or events.
Time Frame: 2 years
2 years
Heart failure hospitalizations or events.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiovascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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