Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Start Date
12/13/2024
Completion Date
9/1/2032
Summary
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
Detailed Description
Patients with heart failure (HF) suffer from a high degree of morbidity and mortality. Left ventricular assist device (LVAD) therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity. However, use of LVADs in ambulatory, non-inotrope dependent advanced HF population is limited. Elevated mean pulmonary artery pressure (PAP) secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy (GDMT). In these patients, left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD. The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor. All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or, if not, will be implanted with the CardioMEMS PA Sensor after enrollment. The overall objectives of TEAM-HF trial are two-fold: 1) To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2) To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT. The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry. The TEAM-HF Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone. The TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to characterize the progression of patients with non-inotrope dependent HF without elevated PAP.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CardioMEMS HF System
HeartMate 3 Left Ventricular Assist System
Guideline Medical Directed Therapy
Conditions
Locations
Banner-University Medical Center Phoenix
Phoenix, Arizona 85006
United States
Baptist Health Medical Center
Little Rock, Arkansas 72205
United States
Sutter Medical Center
Sacramento, California 95816
United States
University of California at San Francisco
San Francisco, California 94143
United States
Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
Shands at the University of Florida
Gainesville, Florida 32610
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
Piedmont Heart Institute
Atlanta, Georgia 30309
United States
Piedmont Augusta Hospital
Augusta, Georgia 30901
United States
WellStar Kennestone Hospital
Marietta, Georgia 30060
United States
University of Chicago
Chicago, Illinois 60637
United States
Advocate Health & Hospitals Corporation
Oakbrook Terrace, Illinois 60181
United States
St. Vincent Hospital
Indianapolis, Indiana 46240
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
Kansas University Medical Center
Kansas City, Kansas 66160
United States
University of Kentucky
Lexington, Kentucky 40536
United States
Norton Hospital
Louisville, Kentucky 40202
United States
Maine Medical Center
Portland, Maine 04102
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan 49503
United States
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
St. Luke's Hospital
Kansas City, Missouri 64111
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United States
New Mexico Heart Institute
Albuquerque, New Mexico 87102
United States
North Shore University Hospital
Manhasset, New York 11030
United States
New York-Presbyterian/Columbia University Medical Center
New York, New York 10032
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Carolinas Medical Center
Charlotte, North Carolina 28203
United States
Christ Hospital
Cincinnati, Ohio 45219
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma 74104
United States
Saint Francis Hospital
Tulsa, Oklahoma 74136
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
Abington Memorial Hospital
Abington, Pennsylvania 19001
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Prisma Health Midlands
Columbia, South Carolina 29203
United States
The Stern Cardiovascular Foundation
Memphis, Tennessee 38120
United States
Ascension Texas Cardiovascular
Austin, Texas 78705
United States
Baylor University Hospital
Dallas, Texas 75246
United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas 77030
United States
Houston Methodist
Houston, Texas 77030
United States
UTHealth Memorial Hermann
Houston, Texas 77030
United States
The Heart Hospital Baylor Plano
Plano, Texas 75093
United States
Scott & White Memorial Hospital
Temple, Texas 76508
United States
University of Utah Hospital
Salt Lake City, Utah 84132
United States
University of Virginia Medical Center
Charlottesville, Virginia 22908
United States
Aurora Medical Group
Milwaukee, Wisconsin 53215
United States
AKH -Wien
Vienna, State of Vienna 1090
Austria
IKEM Prague
Prague, CBohmia 14021
Czechia
Rigshospitalet
Copenhagen, Copenhagen 2100
Denmark
Herzzentrum Leipzig GmbH
Leipzig, Saxony 04289
Germany
Medizinische Hochschule Hannover
Hanover, Saxon 30625
Germany
Deutsches Herzzentrum der Charité
Berlin, State of Berlin 13353
Germany
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont 10126
Italy
Erasmus MC - Thoraxcenter
Rotterdam, Holland 3015 CE
Netherlands
UMC Utrecht
Utrecht, Utrecht 3584 CX
Netherlands
King Fahad Medical City
Riyadh, Riyadh Region 11525
Saudi Arabia
King Faisal Specialist Hospital
Riyadh, Riyadh Region 12713
Saudi Arabia