Moderate Aortic Valve StenosisNCT05149755
Evolut™ EXPAND TAVR II Pivotal Trial
A study testing Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) in people with Moderate Aortic Valve Stenosis, run by Medtronic Cardiovascular at 94 sites in 16 countries.
Trial summary
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Moderate Aortic Valve Stenosis
- What is being tested?
- Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 94 sitesin 16 countries
- Study dates
- 27 Apr 2022to Dec 2034
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
94 sites in 16 countries.
94 sites in 16 countries
United States52 sites
Lehigh Valley Hospital, Inc
Allentown, Pennsylvania, 18103
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109-1274
Mission Hospital
Asheville, North Carolina, 28801
University of Colorado Hospital
Aurora, Colorado, 80045
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Saint Vincents Medical Center
Bridgeport, Connecticut, 06606-4201
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
The University of Vermont
Burlington, Vermont, 05401-1473
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Morton Plant Hospital
Clearwater, Florida, 33756
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Medical City Dallas
Dallas, Texas, 75230
Ascension Saint John Hospital
Detroit, Michigan, 48236
Englewood Hospital & Medical Center
Englewood, New Jersey, 076931
Texas Health Harris Methodist Hospital Fort Worth
Fort Worth, Texas, 76104
University of Florida
Gainesville, Florida, 32608
Spectrum Health
Grand Rapids, Michigan, 49503
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
Hartford Hospital
Hartford, Connecticut, 06106
Terrebonne General Medical Center
Houma, Louisiana, 70360
Houston Methodist Hospital
Houston, Texas, 77030
Saint Vincent's Medical Center Riverside
Jacksonville, Florida, 32204
Kettering Health Main Campus
Kettering, Ohio, 45429
Jewish Hospital
Louisville, Kentucky, 40202
Catholic Medical Center
Manchester, New Hampshire, 03102
Northwell Health
Manhasset, New York, 11030
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, 53215
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
West Virginia University
Morgantown, West Virginia, 26506
The Mount Sinai Hospital
New York, New York, 10029
Orlando Health
Orlando, Florida, 32806
Abrazo Arizone Heart Hospital
Phoenix, Arizona, 85016
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Mayo Clinic
Rochester, Minnesota, 55905
Intermountain Cardiovascular and Thoracic Surgery
Salt Lake City, Utah, 84111
Methodist Hospital San Antonio
San Antonio, Texas, 78229
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204
Baystate Medical Center
Springfield, Massachusetts, 01199
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308-5054
Tampa General Hospital
Tampa, Florida, 33620
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University Heatlh Sciences
Winston-Salem, North Carolina, 27157
Germany6 sites
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189
Universitätsklinikum Bonn
Bonn, 53217
Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund
Dortmund, 44137
Herzzentrum Leipzig GmbH
Leipzig, 04289
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Klinikum der Universität München - Campus Grosshadern
München, 15, 81377
Canada5 sites
Queen Elizabeth II Health Sciences Centre
Halifax, B3H 3A7
London Health Sciences Centre- University Campus
London, Ontario, N6C 2R5
Montreal Heart Hospital
Montreal, Quebec, H1T1C8
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Japan5 sites
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Shonan Kamakura General Hospital
Kanagawa, Kamakura, 247-8533
Kawasaki Saiwai Hospital
Kawasaki, Kanagawa, 212-0014
Osaka Keisatsu Hospital
Osaka, 543-0035
Osaka University Hospital
Osaka, 565-0871
France4 sites
CHRU Brest - Hôpital de la Cavale Blanche
Brest, 29609
Institut Médico-Chirurgical Montsouris
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
CHU de Rennes - Hôpital Pontchaillou
Rennes, Brittany Region
Netherlands4 sites
Catharina Ziekenhuis
Eindhoven
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
St Antonius Ziekenhuis
Nieuwegein, 3435
Erasmus MC
Rotterdam, 3015
Spain4 sites
Hospital Universitari Clínic de Barcelona
Barcelona, 08036
Hospital Universitario Ramón y Cajal
Madrid, 28034
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Hospital Clínico Universitario de Valladolid
Valladolid, 47006
Italy3 sites
Presidio Ospedaliero Gaspare Rodolico
Catania, 95123
Ospedale San Raffaele - Milano
Milan, 20132
IRCCS Policlinico San Donato
San Donato Milanese, 20097
Australia2 sites
The Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, 6150
Austria2 sites
University Hospital Sankt Poelten
Sankt Pölten, 3100
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, 1030
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
Rabin Medical Center- Beilinson Hospital
Petah Tikva, 49100
Ireland1 site
Galway University Hospitals - University Hospital Galway (UHG)
Galway, H91 YR71
About this study
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Read the 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.
- Conditions
- Moderate Aortic Valve Stenosis
- Being tested
- Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
- Keywords
- aortic, stenosis, moderate, valve, TAVR
- Medical subject headings
- Constriction, Pathologic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Measured: 2 years
Secondary outcomes (7)
Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)
Measured: 1 year
Composite of all-cause mortality and heart failure hospitalizations or events.
Measured: 2 years
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Measured: 2 years
Heart failure hospitalizations or events.
Measured: 2 years
All-cause mortality
Measured: 2 years
Unplanned cardiovascular hospitalizations
Measured: 2 years
Days alive and free of unplanned cardiovascular hospitalizations
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start27 Apr 2022
- Primary completionSep 2027 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Sorajja, MD, Principal investigator, Allina Health SystemJosep Rodes-Cabau, MD, Principal investigator, Fondation IUCPQStephan Windecker, Prof., Principal investigator, Inselspital, Universitätsspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149755
- Sponsor's protocol ID
- D00411092
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No