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NCT06526195NARecruiting

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

Abbott Medical Devices

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

Inclusion Criteria: 1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure 2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m² 3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value) 4. NYHA Class IIIB or NYHA Class IV 5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months 6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant 7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group Randomization Criteria: 1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days. 2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days. 3. mean PAP ≥ 30 mmHg. 4. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant. Single Arm Registry Criteria: 1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial. 2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days. 3. mean PAP \<30 mmHg Exclusion Criteria: 1. Subject is \< 18 years of age at the time of informed consent. 2. Dependent on IV inotrope in the last 30 days. 3. Contra-indications to HM3 LVAS or CardioMEMS HF system. 4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy. 5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter. 6. Existence of ongoing MCS. 7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant. 8. History of any solid organ transplant. 9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management. 10. Presence of an active, uncontrolled infection. 11. Complex congenital heart disease. 12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD. 13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis. 14. Planned VAD or Bi-VAD support prior to enrollment. 15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure: 1. An INR ≥ 2.0 not due to anticoagulation therapy 2. An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis. 3. Biopsy proven liver cirrhosis. 4. Need for chronic renal replacement therapy. 5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted. 6. History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis. 7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration. 16. Any condition other than HF that could limit survival to less than 24 months. 17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

Interventions

DEVICE

CardioMEMS HF System

DEVICE

HeartMate 3 Left Ventricular Assist System

OTHER

Guideline Medical Directed Therapy

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Conditions

Heart FailureHeart DiseasesCardiovascular DiseasesPulmonary Hypertension

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