Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

NACompletedINTERVENTIONAL
Enrollment

1,453

Participants

Timeline

Start Date

December 10, 2010

Primary Completion Date

August 31, 2014

Study Completion Date

May 15, 2019

Conditions
Severe Aortic Stenosis
Interventions
DEVICE

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

DEVICE

Surgical Aortic Valve Replacement (SAVR)

Surgical Aortic Valve Replacement (SAVR)

Trial Locations (45)

10016

NYU Langone Medical Center, New York

10029

The Mount Sinai Medical Center, New York

10075

Lenox Hill Hospital, New York

11030

North Shore University Hospital/ Long Island Jewish Hospital, Manhasset

11576

St. Francis Hospital, Roslyn

15213

University of Pittsburgh Medical Center, Pittsburgh

17043

Pinnacle Health, Harrisburg

17822

Geisinger Medical Center, Danville

20010

Washington Hospital Center / Georgetown Hospital, Washington D.C.

21287

Johns Hopkins Hospital, Baltimore

22042

Inova Fairfax Hospital, Falls Church

27157

Wake Forest University - Baptist Medical Center, Winston-Salem

27710

Duke University Medical Center, Durham

30309

Piedmont Heart Institute, Atlanta

30342

Saint Joseph's Hospital of Atlanta, Atlanta

33136

University of Miami Health System / Jackson Memorial Hospital, Miami

33140

Mount Sinai Medical Center, Miami Beach

37232

Vanderbilt University Medical Center, Nashville

43210

The Ohio State University Medical Center - The Richard M. Ross Heart Hospital, Columbus

43214

Riverside Methodist Hospital, Columbus

44106

University Hospitals - Case Medical Center, Cleveland

46290

St. Vincent Heart Center of Indiana, Indianapolis

48109

University of Michigan Health Systems, Ann Arbor

48201

Detroit Medical Center Cardiovascular Institute, Detroit

48236

St. John Hospital and Medical Center, Detroit

49503

Spectrum Health Hospitals, Grand Rapids

50314

Iowa Heart Center, Des Moines

53215

St. Luke's Medical Center - Aurora Health Care, Milwaukee

60153

Loyola University Medical Center, Maywood

66160

University of Kansas Hospital, Kansas City

70360

Cardiovascular Institute of the South/ Terrebone General, Houma

75226

Baylor Heart and Vascular Hospital, Dallas

77030

Texas Heart Institute at St. Luke's Episcopal Hospital, Houston

The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center, Houston

85006

Banner Good Samaritan, Phoenix

90027

Kaiser Permanente - Los Angeles Medical Center, Los Angeles

90033

University of Southern California University Hospital, Los Angeles

94040

El Camino Hospital, Mountain View

94304

VA Palo Alto Health Care System, Palo Alto

99204

Providence Sacred Heart Medical Center, Spokane

06102

Hartford Hospital, Hartford

06520

Yale New Haven Hospital, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

07962

Morristown Memorial Hospital, Morristown

05458

University of Vermont Medical Center, Burlington

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY

NCT01240902 - Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement | Biotech Hunter | Biotech Hunter