850
Participants
Start Date
December 13, 2024
Primary Completion Date
September 30, 2029
Study Completion Date
September 30, 2032
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.
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.
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.
RECRUITING
AKH -Wien, Vienna
RECRUITING
New York-Presbyterian/Columbia University Medical Center, New York
RECRUITING
North Shore University Hospital, Manhasset
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King Fahad Medical City, Riyadh
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King Faisal Specialist Hospital, Riyadh
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Deutsches Herzzentrum der Charité, Berlin
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Allegheny General Hospital, Pittsburgh
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Penn State Milton S. Hershey Medical Center, Hershey
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Abington Memorial Hospital, Abington
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Washington Hospital Center, Washington D.C.
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Carolinas Medical Center, Charlotte
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Prisma Health Midlands, Columbia
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Medical University of South Carolina, Charleston
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WellStar Kennestone Hospital, Marietta
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Piedmont Heart Institute, Atlanta
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Medizinische Hochschule Hannover, Hanover
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Piedmont Augusta Hospital, Augusta
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Shands at the University of Florida, Gainesville
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Cleveland Clinic Florida, Weston
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The Stern Cardiovascular Foundation, Memphis
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University of Kentucky, Lexington
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The Cleveland Clinic Foundation, Cleveland
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Christ Hospital, Cincinnati
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St. Vincent Hospital, Indianapolis
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Henry Ford Hospital, Detroit
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Spectrum Health Butterworth Hospital, Grand Rapids
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Aurora Medical Group, Milwaukee
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Minneapolis Heart Institute, Minneapolis
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Mayo Clinic, Rochester
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Advocate Health & Hospitals Corporation, Oakbrook Terrace
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St. Luke's Hospital, Kansas City
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Kansas University Medical Center, Kansas City
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University of Nebraska Medical Center, Omaha
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Baptist Health Medical Center, Little Rock
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The Heart Hospital Baylor Plano, Plano
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Baylor University Hospital, Dallas
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Scott & White Memorial Hospital, Temple
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CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston
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Ascension Texas Cardiovascular, Austin
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University of Utah Hospital, Salt Lake City
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Banner-University Medical Center Phoenix, Phoenix
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Sutter Medical Center, Sacramento
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Massachusetts General Hospital, Boston
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Herzzentrum Leipzig GmbH, Leipzig
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Erasmus MC - Thoraxcenter, Rotterdam
RECRUITING
UMC Utrecht, Utrecht
Lead Sponsor
Abbott Medical Devices
INDUSTRY