Evolut™ EXPAND TAVR II Pivotal Trial
AI Description
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
- Who can join
- older adult
- Participants
- 650
- Expected completion
- 2034-12
- Funded by
- industry
Conditions studied
Moderate Aortic Valve Stenosis
What is being tested
- DEVICE: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
What it measures
- 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
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Tampa General Hospital
Tampa, FL
Abbott Northwestern Hospital
Minneapolis, MN
Ascension St. Vincent's Riverside
Jacksonville, FL
Aurora St. Luke's Medical Center
Milwaukee, WI
Baystate Medical Center
Springfield, MA
Beth Israel Deaconess Medical Center
Boston, MA
Carilion Roanoke Memorial Hospital
Roanoke, VA
Catholic Medical Center
Manchester, NH
Cleveland Clinic
Cleveland, OH
Corewell Health Butterworth Hospital
Grand Rapids, MI
Deborah Heart & Lung Center
Browns Mills, NJ
Englewood Hospital
Englewood, NJ
Erlanger
Chattanooga, TN
Hartford Hospital
Hartford, CT
Henry Ford St. John Hospital (Detroit)
Detroit, MI
HonorHealth Scottsdale Shea Medical Center
Scottsdale, AZ
Houston Methodist Hospital
Houston, TX
J.W. Ruby Memorial Hospital
Morgantown, WV
Kettering Health Main Campus
Kettering, OH
Lehigh Valley Hospital–Cedar Crest
Allentown, PA
Los Robles Regional Medical Center
Thousand Oaks, CA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
Medical City Heart Hospital (Dallas)
Dallas, TX
MedStar Washington Hospital Center
Washington, DC
Methodist Hospital
San Antonio, TX
Mission Hospital (Asheville)
Asheville, NC
Monument Health Rapid City Hospital
Rapid City, SD
Morton Plant Hospital (Clearwater)
Clearwater, FL
OHSU Hospital
Portland, OR
Orlando Health
Orlando, FL
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, WA
Sandra Atlas Bass Heart Hospital at North Shore University Hospital
Manhasset, NY
SSM Health Saint Louis University Hospital
Saint Louis, MO
St. Vincent's Medical Center
Bridgeport, CT
Tallahassee Memorial HealthCare
Tallahassee, FL
Terrebonne General Medical Center
Houma, LA
Texas Health Harris Methodist Hospital Fort Worth
Fort Worth, TX
The Johns Hopkins Hospital
Baltimore, MD
The Mount Sinai Hospital
New York, NY
The Ohio State University Wexner Medical Center
Columbus, OH
The University of Vermont Medical Center
Burlington, VT
Tufts Medical Center
Boston, MA
UAB Hospital
Birmingham, AL
UF Health Shands Hospital
Gainesville, FL
University Hospitals Cleveland Medical Center
Cleveland, OH
University of Colorado Hospital
Aurora, CO
University of Michigan Health System
Ann Arbor, MI
UofL Health – Jewish Hospital
Louisville, KY
UPMC Harrisburg
Harrisburg, PA
Registry entry updated 2026-05-19
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.