Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

NAActive, not recruitingINTERVENTIONAL
Enrollment

2,223

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

April 30, 2021

Study Completion Date

March 31, 2026

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

Medtronic Transcatheter Aortic Valve Replacement Systems

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

DEVICE

Surgical Aortic Valve Replacement (SAVR)

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

Trial Locations (87)

2010

Saint Vincent's Hospital Sydney, Darlinghurst

2065

Royal North Shore Hospital, St Leonards

3004

The Alfred Hospital, Melbourne

3015

Erasmus Medisch Centrum, Rotterdam

3168

Monash Health, Clayton

3435

St. Antonius Hospital Nieuwegein, Nieuwegein

5623

Catharina Ziekenhuis, Eindhoven

6150

Fiona Stanley Hospital (FSH), Murdoch

10029

The Mount Sinai Hospital, New York

11030

Northwell Health, Manhasset

11548

Saint Francis Hospital, East Hills

13088

Saint Joseph's Hospital Health Center, Liverpool

14642

Strong Memorial Hospital, Rochester

15232

University of Pittsburgh Medical Center UPMC Presbyterian, Pittsburgh

17043

Geinsinger Medical Center, Danville

Pinnacle Health, Harrisburg

18103

Lehigh Valley Hospital, Allentown

19085

Paramount Heart, Villanova

21201

University of Maryland Medical Center, Baltimore

21218

MedStar Union Memorial Hospital, Baltimore

21287

The Johns Hopkins Hospital, Baltimore

23226

Saint Mary's Hospital, Richmond

27157

Wake Forest Baptist Medical Center, Winston-Salem

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30309

Piedmont Atlanta Hospital, Atlanta

31300

Clinique Pasteur, Toulouse

32308

Tallahassee Research Institute, Inc., Tallahassee

33136

University of Miami Hospital, Miami

33484

Delray Medical Center, Delray Beach

33756

Morton Plant Hospital, Clearwater

33908

HealthPark Medical Center, Fort Myers

37232

Vanderbilt University Medical Center, Nashville

40202

Jewish Hospital, Louisville

43210

The Ohio State University, Columbus

43214

OhioHealth Riverside Methodist Hospital, Columbus

44106

University Hospitals Case Medical Center, Cleveland

45220

Good Samaritan Hospital, Cincinnati

46290

Saint Vincent Heart Center of Indiana, Indianapolis

48109

University of Michigan Health System, Ann Arbor

48236

Saint John Hospital and Medical Center, Detroit

49503

Spectrum Health Hospitals, Grand Rapids

50314

Mercy Medical Center, Des Moines

53215

Aurora Saint Luke's Medical Center, Milwaukee

55407

Abbott Northwestern Hospital, Minneapolis

58102

Sanford Medical Center, Fargo

59000

Centre Hospitalier Régional Universitaire de Lille, Lille

60153

Loyola University Medical Center, Maywood

64040

El Camino Hospital, Mountain View

65806

Mercy Hospital, Springfield

66160

The University of Kansas Hospital, Kansas City

70360

Terrebonne General Medical Center, Houma

73112

Integris Baptist Medical Center, Oklahoma City

75204

Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas

77030

Baylor Saint Luke's Medical Center, Houston

Houston Methodist Hospital, Houston

78229

Methodist Hospital San Antonio, San Antonio

80045

University of Colorado Hospital, Aurora

84132

University Hospital Salt Lake City Utah, Salt Lake City

85016

Abrazo Arizona Heart Hospital, Phoenix

90033

University of Southern California University Hospital, Los Angeles

91300

L'Hôpital Privé Jacques Cartier Massy, Massy

91360

Los Robles Hospital & Medical Center, Thousand Oaks

92037

Scripps Memorial Hospital La Jolla, La Jolla

95816

Mercy General Hospital, Sacramento

97239

Oregon Health Science University, Portland

98122

Swedish Medical Center, Seattle

06520

Yale New Haven Hospital, New Haven

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01199

Baystate Medical Center, Springfield

05401

The University of Vermont Medical Center, Burlington

N6A 5A5

London Health Sciences Centre, London

MSG2C4

Toronto General Health Hospital, Toronto

H4A 3J1

Glen Royal Victoria (McGill), Montreal

G1V 4G5

IUCPQ, Québec

H1T 1C8

Montreal Heart, Montreal

Unknown

Sunnybrook Health Sciences Centre, Toronto

Kokura Memorial Hospital, Kitakyushu

Sapporo Higashi Tokushukai Hospital, Sapporo

Teikyo University Hospital, Tokyo

Shonan Kamakura General Hospital, Kamakura

Sendai Kousei Hospital, Sendai

National Cerebral and Cardiovasclular Center, Suita

The University of Osaka Hospital, Suita

Sakakibara Heart Institute, Fuchū

Waikato Hospital, Hamilton

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY

NCT02701283 - Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients | Biotech Hunter | Biotech Hunter