Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement

NATerminatedINTERVENTIONAL
Enrollment

1,425

Participants

Timeline

Start Date

September 22, 2014

Primary Completion Date

March 8, 2017

Study Completion Date

May 21, 2021

Conditions
Aortic Stenosis
Interventions
DEVICE

Lotus Valve System

Procedure: Transcatheter aortic valve replacement (TAVR)

DEVICE

CoreValve/Evolut R Transcatheter Aortic Valve Replacement System

Procedure: Transcatheter aortic valve replacement (TAVR)

DEVICE

LOTUS Edge Valve System

Procedure: Transcatheter aortic valve replacement (TAVR)

Trial Locations (58)

3168

Monash Medical Centre, Clayton

4032

The Prince Charles Hospital, Chermside

10021

Columbia University Medical Center, New York

11030

North Shore University Hospital, Manhasset

14203

Kaleida Health, Buffalo

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

20010

Washington Hospital Center, Washington D.C.

20246

Universitares Herzzentrum UKE (Hamburg), Hamburg

21218

Union Memorial Hospital, Baltimore

22042

Inova Fairfax Hospital, Falls Church

27157

Wake Forest University School of Medicine, Winston-Salem

27607

NC Heart and Vascular Research - Rex Hospital, Raleigh

27710

Duke University Medical Center, Durham

30308

Emory University Hospital, Atlanta

30309

Piedmont Hospital, Atlanta

31059

Centre Hôpital Universitaire Rangueil, Toulouse

31076

Clinique Pasteur, Toulouse

33136

University of Miami Hospital, Miami

33176

Baptist Cardiac and Vascular Institute, Miami

33484

Delray Medical Center, Delray Beach

33756

Morton Plant Mease Healthcare System, Clearwater

43210

Ohio State University Medical Center, Columbus

43214

Ohio Health Research and Innovation Institute - Riverside Methodist Hospital, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45219

Lindner Center for Research and Education at The Christ Hospital, Cincinnati

46290

St. Vincent's Hospital, Indianapolis

48073

William Beaumont Hospital, Royal Oak

48109

University of Michigan, Ann Arbor

49770

Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital, Petoskey

53215

Aurora St. Luke's Medical Center, Milwaukee

55407

Abbott Northwestern Hospital - Minneapolis Heart Institute, Minneapolis

55455

University of Minnesota Medical Center, Minneapolis

55905

Mayo Clinic, Rochester

60201

Evanston Hospital, Evanston

62701

St. John's Hospital - Prairie Cardiovascular Consultants, Springfield

63110

Washington University School of Medicine - Barnes Jewish Medical Center, St Louis

66160

University of Kansas Hospital, Kansas City

75226

Baylor Heart and Vascular Hospital, Dallas

75230

Medical City Dallas Hospital, Dallas

77030

Methodist DeBakey Heart & Vascular Center, Houston

78229

Methodist Heart Hospital, San Antonio

85018

Banner Good Samaritan, Phoenix

85258

Scottsdale Healthcare - Shea, Scottsdale

90048

Cedars-Sinai Medical Center, Los Angeles

92037

Scripps Clinic, La Jolla

94304

Veteran's Administration Palo Alto Medical Center, Palo Alto

94305

Stanford University Medical Center, Stanford

95817

University of California at Davis Medical Center, Sacramento

97225

Providence St. Vincent Medical Center, Portland

98105

University of Washington Medical Center, Seattle

98122

Swedish Medical Center, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

07960

Morristown Memorial Hospital, Morristown

V6Z1Y6

Providence Health - St. Paul's Hospital, Vancouver

H3A

McGill University Health Centre, Royal Victoria Hospital, Montreal

04289

Herzzentrum Universität Leipzig, Leipzig

3015 CE

Erasmus MC - University Medical Center Rotterdam, Rotterdam

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY