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

NCT06526195 | Recruiting DMC FDA Device

• 1 other identifier: ABT- CIP-10521
• Study Type: interventional
• Target: 850
• Locations: 8 countries
• Sites: 63

Brief 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.

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases; Pulmonary Hypertension

Keywords

Heart Failure; Left Ventricular Assist Device (LVAD); Guideline Directed Medical Therapy (GDMT); Non-inotrope Dependent; Pulmonary Artery Pressure; Hemodynamic Monitoring; Medical Management; CardioMEMS; HeartMate 3 (HM3); Ambulatory Advanced Heart Failure

Outcome Measures

Primary Outcomes (1)

• Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes

  The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Intention-to-treat (ITT) population.

  2 years

Secondary Outcomes (8)

• Rate of Safety Outcomes at 1-year

  1 year

• Survival at 2 years

  2 years

• Quality of life score assessed with the Kansas City Cardiomyopathy Questionnaire

  2 years

• Six-minute walk distance

  2 years

• Hospitalizations for HF and/or Urgent HF Visit

  2 years

Other Outcomes (2)

• Finkelstein-Schoenfeld Win Ratio

  5 years

• Survival free of urgent LVAD or transplant

  5 years

Study Arms (3)

Randomized Arm - HM3 Group

EXPERIMENTAL

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization.

Device: CardioMEMS HF System; Device: HeartMate 3 Left Ventricular Assist System; Other: Guideline Medical Directed Therapy

Randomized Arm - Control Group

EXPERIMENTAL

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines.

Device: CardioMEMS HF System; Other: Guideline Medical Directed Therapy

Single Arm Registry

EXPERIMENTAL

Patients who do not meet the mean PAP threshold (mean PAP \<30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines.

Device: CardioMEMS HF System; Other: Guideline Medical Directed Therapy

Interventions

CardioMEMS HF System DEVICE

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

Also known as: CardioMEMS, CardioMEMS PA Sensor

Randomized Arm - Control Group; Randomized Arm - HM3 Group; Single Arm Registry

HeartMate 3 Left Ventricular Assist System DEVICE

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.

Also known as: HM3

Randomized Arm - HM3 Group

Guideline Medical Directed Therapy OTHER

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.

Also known as: GDMT

Randomized Arm - Control Group; Randomized Arm - HM3 Group; Single Arm Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
• LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
• 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)
• NYHA Class IIIB or NYHA Class IV
• Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
• Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
• Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group
• Randomization Criteria:
• Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
• 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.
• mean PAP ≥ 30 mmHg.
• 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:
• Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.
• 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.

You may not qualify if:

• Subject is \< 18 years of age at the time of informed consent.
• Dependent on IV inotrope in the last 30 days.
• Contra-indications to HM3 LVAS or CardioMEMS HF system.
• Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
• Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
• Existence of ongoing MCS.
• Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
• History of any solid organ transplant.
• Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
• Presence of an active, uncontrolled infection.
• Complex congenital heart disease.
• Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
• History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis.
• Planned VAD or Bi-VAD support prior to enrollment.
• Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (63)

Banner-University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

RECRUITING

Sutter Medical Center

Sacramento, California, 95816, United States

RECRUITING

University of California at San Francisco

San Francisco, California, 94143, United States

RECRUITING

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Shands at the University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Piedmont Augusta Hospital

Augusta, Georgia, 30901, United States

RECRUITING

WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

RECRUITING

Advocate Health & Hospitals Corporation

Oakbrook Terrace, Illinois, 60181, United States

RECRUITING

St. Vincent Hospital

Indianapolis, Indiana, 46240, United States

RECRUITING

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74104, United States

RECRUITING

Saint Francis Hospital

Tulsa, Oklahoma, 74136, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

RECRUITING

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Midlands

Columbia, South Carolina, 29203, United States

RECRUITING

The Stern Cardiovascular Foundation

Memphis, Tennessee, 38120, United States

RECRUITING

Ascension Texas Cardiovascular

Austin, Texas, 78705, United States

RECRUITING

Baylor University Hospital

Dallas, Texas, 75246, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

UTHealth Memorial Hermann

Houston, Texas, 77030, United States

RECRUITING

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

RECRUITING

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

RECRUITING

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

RECRUITING

AKH -Wien

Vienna, Vienna, 1090, Austria

RECRUITING

IKEM Prague

Prague, CBohmia, 14021, Czechia

RECRUITING

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

RECRUITING

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 04289, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Saxon, 30625, Germany

RECRUITING

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

RECRUITING

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

Turin, Piedmont, 10126, Italy

RECRUITING

Erasmus MC - Thoraxcenter

Rotterdam, Holland, 3015 CE, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

King Fahad Medical City

Riyadh, Riyadh Region, 11525, Saudi Arabia

RECRUITING

King Faisal Specialist Hospital

Riyadh, Riyadh Region, 12713, Saudi Arabia

RECRUITING

Related Links

• TEAM-HF Clinical Trial Patient Information

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Kelly O'Connell, PhD

  Abbott

  STUDY DIRECTOR

Central Study Contacts

Nourdine Chakouri, PhD

CONTACT

925-989-5982; nourdine.chakouri@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2032
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2); AU (1); IT (1); CZ (1); US (52); DE (3); NL (2); DK (1)