REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects

NATerminatedINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

January 14, 2019

Primary Completion Date

March 30, 2021

Study Completion Date

March 31, 2021

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

LOTUS Edge Valve System

TAVR with the LOTUS Edge Valve System

Trial Locations (50)

3168

Monash Cardiovascular Research Centre, Clayton

10010

NYU Langone Medical Center, New York

10032

Columbia University Medical Center/NewYork Presbyterian Hospital, New York

11030

North Shore University Hospital, Manhasset

11501

NYU Winthrop Hospital, Mineola

15212

Allegheny General Hospital, Pittsburgh

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania, Philadelphia

20010

Medstar Heart and Vascular Institute, Washington D.C.

22042

Inova Fairfax Hospital, Annandale

26506

WVU Heart & Vascular Institute, Morgantown

27607

UNC Rex Hospital, Raleigh

28204

Novant Health Heart & Vascular Institute - Charlotte, Charlotte

29605

Greenville Memorial Hospital - Prisma Health, Greenville

30060

Wellstar Research Institute, Marietta

30309

Piedmont Heart Institute, Atlanta

32605

North Florida Regional Medical Center, Gainesville

32803

AdventHealth Orlando, Orlando

33462

JFK Medical Center, Atlantis

35801

Huntsville Hospital, Huntsville

37203

Centennial Medical Center, Nashville

37212

Vanderbilt University Medical Center, Nashville

45219

The Lindner Center for Research and Education, Cincinnati

46202

Indiana University Health - Methodist Hospital, Indianapolis

48073

Beaumont Hospital, Royal Oak

49503

Spectrum Health - Grand Rapids, Grand Rapids

49770

Cardiac & Vascular Research Center of Northern Michigan, Petoskey

53215

Aurora St. Luke's Medical Center, Milwaukee

53226

Froedtert Hospital - Medical College of Wisconsin, Milwaukee

56303

St. Cloud Hospital, Saint Cloud

60201

NorthShore University HealthSystem, Evanston

67214

Via Christi Hospital, Wichita

70121

Ochsner Medical Center, New Orleans

72211

Arkansas Heart Hospital, Little Rock

75093

Baylor Scott & White The Heart Hospital, Plano

77030

Memorial Hermann - Texas Medical Center, Houston

University of Texas - Memorial Hermann Southwest, Houston

80218

Saint Joseph Hospital, Denver

85712

Tucson Medical Center, Tucson

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90033

USC Medical Center, Los Angeles

94010

Mills-Peninsula Medical Center - Sutter Health, Burlingame

97225

Providence St. Vincent Medical Center, Portland

98122

Swedish Medical Center, Seattle

98195

University of Washington, Seattle

06510

Yale New Haven Hospital, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

02720

Charlton Memorial Hospital - Southcoast Health, Fall River

07631

Englewood Hospital, Englewood

07960

Morristown Medical Center, Morristown

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY