New TAVR care pathway shows promise in 1,127 patients

NCT ID NCT04091048

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

First seen Nov 15, 2025 · Last updated Jun 23, 2026 · Updated 21 times

Summary

This study looked at whether a special care plan could improve results for people getting a new heart valve through a less invasive procedure called TAVR. Over 1,100 patients with a narrowed heart valve (aortic stenosis) took part. The goal was to see if the new approach reduces death, stroke, and other problems after the procedure.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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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

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 replacement devices

What this could lead to

If successful, this could confirm that an optimized care pathway improves recovery and reduces complications after TAVR for aortic stenosis.

What could go wrong

This is a completed post-market study, so results are already in. However, individual outcomes may vary, and risks like stroke or need for a pacemaker remain.

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 SYMPTOMATIC AORTIC STENOSIS