RecruitingNot ApplicableNCT06526195

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

Sponsor

Abbott Medical Devices

Enrollment

850 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cardiovascular Diseases Pulmonary Hypertension Heart Diseases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether implanting a mechanical heart pump (called an LVAD, or left ventricular assist device — specifically the HeartMate 3) improves survival and quality of life in patients with advanced heart failure compared to staying on optimized medication therapy alone. Patients must also have a pressure sensor implanted in their pulmonary artery (CardioMEMS) to monitor heart pressures remotely. **You may be eligible if...** - You are 18 or older - You have advanced heart failure with a very low heart pumping function (ejection fraction of 30% or below) - You are significantly limited in physical activity and have been hospitalized for heart failure at least once in the past year - You are willing to potentially receive a mechanical heart pump (LVAD) if randomized to that group **You may NOT be eligible if...** - You are currently dependent on IV medications to support heart function - You have heart failure caused by uncorrected thyroid disease, obstructive heart disease, amyloidosis, or restrictive/pericardial cardiomyopathy - You have had an organ transplant - You have severe kidney disease, liver cirrhosis, or severe lung disease - You have significant blood vessel disease or history of stroke - You are pregnant or could become pregnant and are unwilling to use contraception with an LVAD Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardioMEMS HF System

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

DEVICEHeartMate 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.

OTHERGuideline 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.

Locations(63)

Banner-University Medical Center Phoenix

Phoenix, Arizona, United States

Baptist Health Medical Center

Little Rock, Arkansas, United States

Sutter Medical Center

Sacramento, California, United States

University of California at San Francisco

San Francisco, California, United States

Washington Hospital Center

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

Shands at the University of Florida

Gainesville, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Piedmont Augusta Hospital

Augusta, Georgia, United States

WellStar Kennestone Hospital

Marietta, Georgia, United States

Advocate Health & Hospitals Corporation

Oakbrook Terrace, Illinois, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Norton Hospital

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Luke's Hospital

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

North Shore University Hospital

Manhasset, New York, United States

New York-Presbyterian/Columbia University Medical Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Christ Hospital

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, United States

Saint Francis Hospital

Tulsa, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Midlands

Columbia, South Carolina, United States

The Stern Cardiovascular Foundation

Memphis, Tennessee, United States

Ascension Texas Cardiovascular

Austin, Texas, United States

Baylor University Hospital

Dallas, Texas, United States

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

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

UTHealth Memorial Hermann

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Scott & White Memorial Hospital

Temple, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Aurora Medical Group

Milwaukee, Wisconsin, United States

AKH -Wien

Vienna, State of Vienna, Austria

IKEM Prague

Prague, CBohmia, Czechia

Rigshospitalet

Copenhagen, Copenhagen, Denmark

Herzzentrum Leipzig GmbH

Leipzig, Saxony, Germany

Medizinische Hochschule Hannover

Hanover, Saxon, Germany

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, Germany

A.O.U. Citta della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Erasmus MC - Thoraxcenter

Rotterdam, Holland, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

King Fahad Medical City

Riyadh, Riyadh Region, Saudi Arabia

King Faisal Specialist Hospital

Riyadh, Riyadh Region, Saudi Arabia

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