Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure

NARecruitingINTERVENTIONAL
Enrollment

850

Participants

Timeline

Start Date

December 13, 2024

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2032

Conditions
Heart FailureHeart DiseasesCardiovascular DiseasesPulmonary Hypertension
Interventions
DEVICE

CardioMEMS HF System

The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.

DEVICE

HeartMate 3 Left Ventricular Assist System

The HeartMate 3 LVAS is a mechanical circulatory support pump with Full MagLev Technology that assumes some or all of the workload of the left ventricle. The HeartMate 3 LVAS is used in advanced heart failure patients needing short or long-term mechanical circulatory support.

OTHER

Guideline Medical Directed Therapy

Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.

Trial Locations (46)

1090

RECRUITING

AKH -Wien, Vienna

10032

RECRUITING

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

11030

RECRUITING

North Shore University Hospital, Manhasset

11525

RECRUITING

King Fahad Medical City, Riyadh

12713

RECRUITING

King Faisal Specialist Hospital, Riyadh

13353

RECRUITING

Deutsches Herzzentrum der Charité, Berlin

15212

RECRUITING

Allegheny General Hospital, Pittsburgh

17033

RECRUITING

Penn State Milton S. Hershey Medical Center, Hershey

19001

RECRUITING

Abington Memorial Hospital, Abington

20010

RECRUITING

Washington Hospital Center, Washington D.C.

28203

RECRUITING

Carolinas Medical Center, Charlotte

29203

RECRUITING

Prisma Health Midlands, Columbia

29425

RECRUITING

Medical University of South Carolina, Charleston

30060

RECRUITING

WellStar Kennestone Hospital, Marietta

30309

RECRUITING

Piedmont Heart Institute, Atlanta

30625

RECRUITING

Medizinische Hochschule Hannover, Hanover

30901

RECRUITING

Piedmont Augusta Hospital, Augusta

32610

RECRUITING

Shands at the University of Florida, Gainesville

33331

RECRUITING

Cleveland Clinic Florida, Weston

38120

RECRUITING

The Stern Cardiovascular Foundation, Memphis

40536

RECRUITING

University of Kentucky, Lexington

44195

RECRUITING

The Cleveland Clinic Foundation, Cleveland

45219

RECRUITING

Christ Hospital, Cincinnati

46240

RECRUITING

St. Vincent Hospital, Indianapolis

48202

RECRUITING

Henry Ford Hospital, Detroit

49503

RECRUITING

Spectrum Health Butterworth Hospital, Grand Rapids

53215

RECRUITING

Aurora Medical Group, Milwaukee

55407

RECRUITING

Minneapolis Heart Institute, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

60181

RECRUITING

Advocate Health & Hospitals Corporation, Oakbrook Terrace

64111

RECRUITING

St. Luke's Hospital, Kansas City

66160

RECRUITING

Kansas University Medical Center, Kansas City

68198

RECRUITING

University of Nebraska Medical Center, Omaha

72205

RECRUITING

Baptist Health Medical Center, Little Rock

75093

RECRUITING

The Heart Hospital Baylor Plano, Plano

75246

RECRUITING

Baylor University Hospital, Dallas

76508

RECRUITING

Scott & White Memorial Hospital, Temple

77030

RECRUITING

CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston

78705

RECRUITING

Ascension Texas Cardiovascular, Austin

84132

RECRUITING

University of Utah Hospital, Salt Lake City

85006

RECRUITING

Banner-University Medical Center Phoenix, Phoenix

95816

RECRUITING

Sutter Medical Center, Sacramento

02114

RECRUITING

Massachusetts General Hospital, Boston

04289

RECRUITING

Herzzentrum Leipzig GmbH, Leipzig

3015 CE

RECRUITING

Erasmus MC - Thoraxcenter, Rotterdam

3584 CX

RECRUITING

UMC Utrecht, Utrecht

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY