The JenaValve ALIGN-AR Pivotal Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

May 22, 2020

Primary Completion Date

August 29, 2023

Study Completion Date

August 31, 2028

Conditions
Aortic RegurgitationAortic Valve InsufficiencyAortic InsufficiencyAortic Valve Disease
Interventions
DEVICE

JenaValve Trilogy Heart Valve System

TAVR with JenaValve Trilogy Heart Valve System

Trial Locations (30)

10032

New York-Presbyterian/ Columbia University Medical Center, New York

15212

Allegheny-Singer Health Network, Pittsburgh

19096

Lankenau, Wynnewood

20010

MedStar Washington Hospital Center, Washington D.C.

21201

University of Maryland Medical Center, Baltimore

23502

Sentara Hospitals, Norfolk

29425

Medical University of South Carolina, Charleston

30309

Piedmont Healthcare, Atlanta

30322

Emory University Hospital, Atlanta

33756

Morton Plant/ BayCare Health, Clearwater

38104

Methodist Le Bonheur Healthcare, Memphis

43214

Ohio Health Research Institute, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45219

The Christ Hospital, Cincinnati

48109

University of Michigan, Ann Arbor

48202

Henry Ford Health System, Detroit

55407

Minneapolis Heart Institute/ Abbott Northwestern, Minneapolis

60453

Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health, Oak Lawn

63110

Barnes-Jewish Hospital / Washington University, St Louis

75201

Baylor Scott & White Research Institute, Dallas

77030

Houston Methodist, Houston

Memorial Hermann - Texas Medical Center, Houston

84111

Intermountain Medical Center Heart Institute, Salt Lake City

85712

TMC HealthCare & PIMA Heart, Tucson

90048

Cedars Sinai Medical Center, Los Angeles

92121

Scripps Hospital, San Diego

94109

California Pacific Medical Center Research Institute, San Francisco

97239

Oregon Health & Science University, Portland

98195

University of Washington, Seattle

08901

Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital, Piscataway

Sponsors
All Listed Sponsors
lead

JenaValve Technology, Inc.

INDUSTRY

NCT04415047 - The JenaValve ALIGN-AR Pivotal Trial | Biotech Hunter | Biotech Hunter