New heart valve study aims to cut complications in aortic stenosis patients

NCT ID NCT04091048

Completed Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an optimized care plan for people with a narrowed aortic heart valve who received a new valve through a catheter (TAVR). Over 1,100 patients were enrolled to see if the improved care pathway could lower risks like death, stroke, and the need for a pacemaker. The goal is to make a common heart procedure safer and more effective.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Evolut PRO and Evolut PRO+ heart valve devices
What this could lead to: If successful, this could help standardize a safer, more effective care pathway for patients needing aortic valve replacement, reducing complications like stroke and pacemaker need.
What could go wrong: This is a post-market study, not a randomized trial, so results may not prove superiority over other approaches. Risks of TAVR include bleeding, stroke, and need for a pacemaker.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SYMPTOMATIC AORTIC STENOSIS

Contacts and locations

Locations

Abbott Northwestern Hospital (Minneapolis Heart)

Minneapolis, Minnesota, 55407, United States
Akademiska Sjukhuset

Uppsala, Sweden
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Ascension St. John Hospital

Detroit, Michigan, 48236, United States
Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53125, United States
Austin Hospital

Heidelberg, Australia
Buffalo General Medical Center

Buffalo, New York, 14203, United States
California Pacific Medical Center - Sutter Health

San Francisco, California, 94109, United States
Charleston Medical Center

Charleston, West Virginia, 25304, United States
Dixie Regional Medical Center Intermountain

St. George, Utah, 84770, United States
Emory University Hospital

Atlanta, Georgia, 30308, United States
Fiona Stanley Hospital

Murdoch, Australia
Fondazione Poliambulanza

Brescia, Italy
Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy
Galway University Hospitals - University Hospital Galway (UHG)

Galway, Ireland
Hartford Hospital

Hartford, Connecticut, 06102, United States
Hospital Universitario Central de Asturas

Oviedo, Spain
Houston Methodist Hospital

Houston, Texas, 77030, United States
Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, France
Hôpitaux Universitaires - Hôpital Henri Mondor

Créteil, France
Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States
John Hunter Hospital

Newcastle, Australia
Kettering Medical Center

Kettering, Ohio, 45429, United States
Laval University Institute of Cardiology and Respirology of Quebec

Québec, Quebec, G1V 4G5, Canada
Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18103, United States
Manchester Royal Infirmary

Manchester, United Kingdom
Mater Private Hospital

Dublin, Ireland
Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States
Monash Hospital

Clayton, Australia
Morton Plant Hospital

Clearwater, Florida, 33756, United States
New York Presbyterian - Columbia University Medical Center

New York, New York, 10032, United States
Ohio Health Research Institute

Columbus, Ohio, 43214, United States
Providence St. Patrick Hospital

Missoula, Montana, 59802, United States
Royal Victoria Hospital - Belfast Health and Social Care Trust

Belfast, United Kingdom
Rush University Medical Center

Chicago, Illinois, 60612, United States
Saint Vincents Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia
Saint Vincents Hospital Sydney

Sydney, Australia
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Shaare Zedek Medical Center

Jerusalem, Israel
Spectrum Health

Grand Rapids, Michigan, 49503, United States
St Jan Hospital

Bruges, Belgium
St. Francis Hospital

Roslyn, New York, 11576, United States
St. John's Hospital/Prarie Education and Research Cooperative

Springfield, Illinois, 62769, United States
St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.

Norwalk, Connecticut, 06851, United States
Stony Brook University Hospital

Stony Brook, New York, 11794, United States
Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
The Heart Hospital - Baylor Plano

Plano, Texas, 75093, United States
The Mount Sinai Hospital

New York, New York, 10029, United States
The Prince Charles Hospital

Chermside West, Australia
The Valley Hospital

Ridgewood, New Jersey, 07450, United States
UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17101, United States
UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States
University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States
Universitätsklinikum Ulm

Ulm, Germany
Vassar Brother's Medical Center

Poughkeepsie, New York, 12601, United States
Yale New Haven Hospital

New Haven, Connecticut, 06510, United States
York Hospital

York, Pennsylvania, 17403, United States
ZNA Middelheim

Antwerp, Belgium

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