Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03242642

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Led by Medtronic Cardiovascular · Updated on 2026-05-05

1056

Participants Needed

85

Research Sites

988 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

CONDITIONS

Official Title

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate to severe or severe symptomatic mitral regurgitation
  • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
Not Eligible

You will not qualify if you...

  • Prior transcatheter mitral valve procedure with device currently implanted
  • Anatomic contraindications
  • Prohibitive mitral annular calcification
  • Left ventricular ejection fraction <25%
  • Need for emergent or urgent surgery
  • Hemodynamic instability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 85 locations

1

University of Alabama Birmingham (UAB) Hospital

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Abrazo Heart Hospital

Phoenix, Arizona, United States, 85018

Actively Recruiting

3

Scripps Memorial Hospital

La Jolla, California, United States, 92037

Actively Recruiting

4

PIH Health Good Samaritan Hospital

Los Angeles, California, United States, 90017

Actively Recruiting

5

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

Actively Recruiting

6

Keck Hospital of the University of Southern California, USC

Los Angeles, California, United States, 90033

Actively Recruiting

7

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

8

El Camino Hospital

Mountain View, California, United States, 94040

Actively Recruiting

9

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States, 94118-3100

Actively Recruiting

10

Stanford Hospital and Clinics

Stanford, California, United States, 94305

Actively Recruiting

11

Los Robles Regional Medical Center

Thousand Oaks, California, United States, 91360-1847

Actively Recruiting

12

Hartford Hospital

Hartford, Connecticut, United States, 06102

Actively Recruiting

13

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

14

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

15

JFK Medical Center

Atlantis, Florida, United States, 33462

Actively Recruiting

16

Morton Plant

Clearwater, Florida, United States, 33756

Actively Recruiting

17

HealthPark Medical Center

Fort Myers, Florida, United States, 33908

Actively Recruiting

18

North Florida Regional Medical Center

Gainesville, Florida, United States, 32605

Actively Recruiting

19

Baptist Medical Center Jacksonville

Jacksonville, Florida, United States, 32207

Actively Recruiting

20

University of South Florida Health

Tampa, Florida, United States, 33606

Actively Recruiting

21

Emory University

Atlanta, Georgia, United States, 30308

Actively Recruiting

22

Piedmont Atlanta Hospital

Atlanta, Georgia, United States, 30309

Actively Recruiting

23

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

24

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

25

MercyOne Des Moines Medical Center

Des Moines, Iowa, United States, 50314

Actively Recruiting

26

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

27

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Completed

28

The Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

29

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

30

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

31

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

32

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

33

Henry Ford Saint John Hospital

Detroit, Michigan, United States, 48236

Actively Recruiting

34

Corewell Health

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

35

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

36

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

37

Barnes-Jewish Hospital

St Louis, Missouri, United States, 63110-1003

Actively Recruiting

38

Providence St Patrick

Missoula, Montana, United States, 59802-4008

Actively Recruiting

39

Morristown Medical Center

Morristown, New Jersey, United States, 07960

Actively Recruiting

40

Jersey Shore University Medical Center

Neptune City, New Jersey, United States, 07753

Actively Recruiting

41

Northwell Health North Shore University Hospital

Manhasset, New York, United States, 11030

Actively Recruiting

42

NYU Langone Hospital - Long Island

Mineola, New York, United States, 11501

Actively Recruiting

43

NYU Langone Medical Center

New York, New York, United States, 10016

Actively Recruiting

44

The Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

45

New York-Presbyterian Hospital Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

46

Montefiore Medical Center

New York, New York, United States, 10467-2401

Actively Recruiting

47

Saint Francis Hospital

Roslyn, New York, United States, 11576

Actively Recruiting

48

Duke University Medical Center

Durham, North Carolina, United States, 27710

Withdrawn

49

The Christ Hospital

Cincinnati, Ohio, United States, 45219-2906

Actively Recruiting

50

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

51

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

52

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States, 43214

Actively Recruiting

53

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States, 73112

Actively Recruiting

54

Providence Saint Vincent Medical Center

Portland, Oregon, United States, 97225

Actively Recruiting

55

Oregon Health & Science University Hospital

Portland, Oregon, United States, 97239

Actively Recruiting

56

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, United States, 17101

Actively Recruiting

57

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

58

Lankenau Medical Center

Wynnewood, Pennsylvania, United States, 19096

Actively Recruiting

59

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

60

Heart Hospital of Austin

Austin, Texas, United States, 78756

Actively Recruiting

61

Texas Health Presbyterian Hospital Dallas

Dallas, Texas, United States, 75231

Actively Recruiting

62

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, United States, 75246

Withdrawn

63

CHI Saint Luke's Health-Baylor Saint Luke's Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

64

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

65

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

66

The Heart Hospital Baylor Plano

Plano, Texas, United States, 75093

Actively Recruiting

67

Methodist Hospital

San Antonio, Texas, United States, 78229

Actively Recruiting

68

The University of Vermont Medical Center

Burlington, Vermont, United States, 05401-1473

Actively Recruiting

69

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22908

Actively Recruiting

70

Inova Fairfax Hospital

Fairfax, Virginia, United States, 22042

Actively Recruiting

71

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507-1904

Actively Recruiting

72

Saint Mary's Hospital/Bon Secours

Richmond, Virginia, United States, 23226

Withdrawn

73

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States, 24014

Actively Recruiting

74

Winchester Medical Center

Winchester, Virginia, United States, 22601

Active, Not Recruiting

75

The Swedish Medical Center Cherry Hill

Seattle, Washington, United States, 98122

Withdrawn

76

University of Washington (UW) Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

77

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States, 99204

Actively Recruiting

78

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

Actively Recruiting

79

Royal Columbian Hospital

New Westminster, British Columbia, Canada, V3L 3W7

Actively Recruiting

80

Saint Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

81

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

82

Saint Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

83

Montreal Heart Insitute

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

84

Glen Royal Victoria Hospital

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

85

Rigshospitalet

Copenhagen, Denmark, 2100

Withdrawn

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Research Team

M

Megan Wilder Fredrickson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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