ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

NAEnrolling by invitationINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2036

Conditions
Aortic Valve StenosisHeart Valve DiseasesAortic Valve DiseaseHeart Disease Structural Disorder
Interventions
DEVICE

Navitor Transcatheter Aortic Valve Implantation (TAVI) System

TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

DEVICE

Any Commercially Available Transcatheter Aortic Valve (CAV) System

TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

Trial Locations (66)

10010

New York University Langone Medical Center - Tisch Hospital, New York

10029

Mount Sinai Hospital, New York

10032

Columbia University Medical Center/NYPH, New York

10467

Montefiore Medical Center - Moses Division, New York

11501

Winthrop-University Hospital, Mineola

15212

Allegheny General Hospital - ASRI, Pittsburgh

15232

University of Pittsburgh Medical Center, Pittsburgh

17055

Pinnacle Health System, Mechanicsburg

19096

Lankenau Institute for Medical Research, Wynnewood

20010

Washington Hospital Center, Washington D.C.

22908

University of Virginia Medical Center, Charlottesville

23507

Sentara Norfolk General Hospital, Norfolk

27834

East Carolina Heart Institute, Greenville

28801

Mission Health & Hospitals, Asheville

30309

Piedmont Heart Institute, Atlanta

30501

Northeast Georgia Medical Center, Gainesville

32308

Tallahassee Research Institute, Tallahassee

32825

AdventHealth Orlando, Orlando

33176

Baptist Hospital of Miami, Miami

33462

HCA Florida - JFK Hospital, Atlantis

33770

HCA Florida Largo Hospital, Largo

34471

HCA Florida Ocala Hospital, Ocala

37232

Vanderbilt University Medical Center, Nashville

38120

Baptist Memorial Hospital, Memphis

43113

Ohio Health Research Institute, Columbus

44195

The Cleveland Clinic, Cleveland

45219

Christ Hospital, Cincinnati

46290

Ascension St. Vincent, Indianapolis

48109

University of Michigan, Ann Arbor

48202

Henry Ford Hospital, Detroit

48670

MyMichigan Medical Center Midland, Midland

49048

Borgess Medical Center, Kalamazoo

53215

Aurora Medical Group, Milwaukee

57108

North Central Heart, Sioux Falls

60201

Endeavor Health, Evanston

Northwestern Memorial Hospital, Evanston

60637

University of Chicago Medical Center, Chicago

64111

Saint Luke's Hospital of Kansas City, Kansas City

67226

Via Christi Regional Medical Center - St. Francis Campus, Wichita

70121

Ochsner Medical Center, New Orleans

72211

Arkansas Heart Hospital, Little Rock

74104

Hillcrest Medical Center, Tulsa

75093

Baylor Scott & White - The Heart Hospital Plano, Plano

75390

University of Texas Southwestern Medical Center, Dallas

77030

Memorial Hermann Hospital, Houston

The Methodist Hospital, Houston

78705

Ascension Texas Cardiovascular, Austin

80218

St. Joseph's Hospital & Medical Center, Denver

84790

Intermountain Health St George Regional Hospital, St. George

85013

St. Joseph's Hospital & Medical Center, Phoenix

87106

Presbyterian Hospital, Albuquerque

91360

Los Robles Regional Medical Center, Thousand Oaks

92037

Southern California Permanente Medical Group - La Jolla, La Jolla

92335

Kaiser Permanente Fontana Medical Center, Fontana

94143

University of California at San Francisco, San Francisco

94305

Stanford University Medical Center, Stanford

96814

The Queen's Medical Center, Honolulu

98122

Swedish Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

07962

Morristown Medical Center, Morristown

V6E 1M7

St. Paul's Hospital, Vancouver

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

M5B 1W8

St. Michael's Hospital, Toronto

H1T 1C8

Institut de Cardiologie de Montreal (Montreal Heart Inst.), Montreal

H4A3J1

The Royal Victoria Hospital, Montreal

NB E2L 4L4

Saint John Regional Hospital - New Brunswick Heart Centre, Saint John

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY