Optimize PRO Study

CompletedOBSERVATIONAL
Enrollment

1,127

Participants

Timeline

Start Date

September 16, 2019

Primary Completion Date

December 15, 2023

Study Completion Date

November 13, 2024

Conditions
Symptomatic Aortic Stenosis
Interventions
DEVICE

Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)

Aortic valve replacement

Trial Locations (60)

2010

Saint Vincents Hospital Sydney, Darlinghurst

10029

The Mount Sinai Hospital, New York

10032

New York Presbyterian - Columbia University Medical Center, New York

11576

St. Francis Hospital, Roslyn

11794

Stony Brook University Hospital, Stony Brook

12601

Vassar Brother's Medical Center, Poughkeepsie

14203

Buffalo General Medical Center, Buffalo

15212

Allegheny General Hospital, Pittsburgh

15213

UPMC Presbyterian, Pittsburgh

17101

UPMC Pinnacle Harrisburg, Harrisburg

17403

York Hospital, York

18103

Lehigh Valley Hospital - Cedar Crest, Allentown

21218

Medstar Union Memorial Hospital, Baltimore

23507

Sentara Norfolk General Hospital, Norfolk

25304

Charleston Medical Center, Charleston

30308

Emory University Hospital, Atlanta

33756

Morton Plant Hospital, Clearwater

35233

University of Alabama at Birmingham Hospital, Birmingham

43214

Ohio Health Research Institute, Columbus

45429

Kettering Medical Center, Kettering

48109

University of Michigan, Ann Arbor

48236

Ascension St. John Hospital, Detroit

49503

Spectrum Health, Grand Rapids

53125

Aurora Saint Luke's Medical Center, Milwaukee

55407

Abbott Northwestern Hospital (Minneapolis Heart), Minneapolis

59802

Providence St. Patrick Hospital, Missoula

60612

Rush University Medical Center, Chicago

62769

St. John's Hospital/Prarie Education and Research Cooperative, Springfield

68105

University of Nebraska Medical Center, Omaha

75093

The Heart Hospital - Baylor Plano, Plano

77030

Houston Methodist Hospital, Houston

84770

Dixie Regional Medical Center Intermountain, St. George

94109

California Pacific Medical Center - Sutter Health, San Francisco

06102

Hartford Hospital, Hartford

06510

Yale New Haven Hospital, New Haven

06851

St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C., Norwalk

07753

Jersey Shore University Medical Center, Neptune City

07450

The Valley Hospital, Ridgewood

Unknown

The Prince Charles Hospital, Chermside West

Monash Hospital, Clayton

Austin Hospital, Heidelberg

Fiona Stanley Hospital, Murdoch

John Hunter Hospital, Newcastle

Saint Vincents Hospital Sydney, Sydney

ZNA Middelheim, Antwerp

St Jan Hospital, Bruges

Hôpitaux Universitaires - Hôpital Henri Mondor, Créteil

Hôpital Haut-Lévêque - CHU de Bordeaux, Pessac

Universitätsklinikum Ulm, Ulm

Mater Private Hospital, Dublin

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

Shaare Zedek Medical Center, Jerusalem

Fondazione Poliambulanza, Brescia

Fondazione Policlinico Universitario Agostino Gemelli, Roma

Hospital Universitario Central de Asturas, Oviedo

Akademiska Sjukhuset, Uppsala

Royal Victoria Hospital - Belfast Health and Social Care Trust, Belfast

Manchester Royal Infirmary, Manchester

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

G1V 4G5

Laval University Institute of Cardiology and Respirology of Quebec, Québec

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY

NCT04091048 - Optimize PRO Study | Biotech Hunter | Biotech Hunter