SURTAVI
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
AI Description
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.
Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
- Who can join
- child, adult, older adult
- Participants
- 1746
- Expected completion
- 2026-11
- Funded by
- industry
Conditions studied
Severe Aortic Stenosis
What is being tested
- DEVICE: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- DEVICE: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- PROCEDURE: Surgical Aortic Valve Replacement (SAVR)
What it measures
- All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability, All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline., 24 months
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Ascension St. Vincent Heart Center
Carmel, IN
Atrium Health Carolinas Medical Center
Charlotte, NC
Aurora St. Luke's Medical Center
Milwaukee, WI
Banner – University Medical Center Phoenix
Phoenix, AZ
Baptist Memorial Hospital-Memphis
Memphis, TN
Baylor Scott & White The Heart Hospital – Dallas
Dallas, TX
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Beth Israel Deaconess Medical Center
Boston, MA
Bon Secours St. Mary's Hospital
Richmond, VA
Cedars-Sinai Medical Center
Los Angeles, CA
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha, NE
Cooper University Hospital
Camden, NJ
Corewell Health Butterworth Hospital
Grand Rapids, MI
Delray Medical Center
Delray Beach, FL
Duke University Hospital
Durham, NC
El Camino Health
Mountain View, CA
Emory University Hospital Midtown
Atlanta, GA
Geisinger Medical Center
Danville, PA
Good Samaritan Hospital (Cincinnati)
Cincinnati, OH
Hartford Hospital
Hartford, CT
Henry Ford Health (Detroit)
Detroit, MI
Henry Ford St. John Hospital (Detroit)
Detroit, MI
Hospital of the University of Pennsylvania
Philadelphia, PA
Houston Methodist Hospital
Houston, TX
Intermountain Medical Center
Murray, UT
Keck Hospital of USC
Los Angeles, CA
Lenox Hill Hospital
New York, NY
Loyola University Medical Center
Maywood, IL
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
MedStar Washington Hospital Center
Washington, DC
Morristown Medical Center
Morristown, NJ
Morton Plant Hospital (Clearwater)
Clearwater, FL
NYU Langone Health
New York, NY
OhioHealth Riverside Methodist Hospital
Columbus, OH
Oklahoma Heart Hospital (Oklahoma City)
Oklahoma City, OK
Piedmont Atlanta Hospital
Atlanta, GA
Saint Luke’s Hospital of Kansas City
Kansas City, MO
Sandra Atlas Bass Heart Hospital at North Shore University Hospital
Manhasset, NY
Scripps Memorial Hospital La Jolla
La Jolla, CA
Sentara Norfolk General Hospital
Norfolk, VA
St. Francis Hospital & Heart Center
Roslyn, NY
Stanford Health Care
Stanford, CA
Strong Memorial Hospital
Rochester, NY
The Johns Hopkins Hospital
Baltimore, MD
The Mount Sinai Hospital
New York, NY
The Ohio State University Wexner Medical Center
Columbus, OH
The Queen’s Medical Center
Honolulu, HI
The University of Kansas Health System
Kansas City, KS
The University of Vermont Medical Center
Burlington, VT
University Hospitals Cleveland Medical Center
Cleveland, OH
University of Michigan Health System
Ann Arbor, MI
UPMC Harrisburg
Harrisburg, PA
UPMC Presbyterian Shadyside
Pittsburgh, PA
Vanderbilt University Medical Center
Nashville, TN
Yale New Haven Hospital
New Haven, CT
Registry entry updated 2026-06-24
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.