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

Recruiting now · Not applicable

Conditions studied: Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT06526195

Run by

Abbott Medical Devices

People needed

850

Starts

2024-12-13

Expected to finish

2032-09-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• mean PAP <30 mmHg

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:
• An INR ≥ 2.0 not due to anticoagulation therapy
• An eGFR < 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
• Biopsy proven liver cirrhosis.
• Need for chronic renal replacement therapy.
• History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 < 30% predicted.
• History of cerebrovascular disease with significant (> 80%) uncorrected internal carotid stenosis.
• Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.
• Any condition other than HF that could limit survival to less than 24 months.
• Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

Where it is running

• Baptist Health Medical Center — Little Rock, Arkansas, United States (enrolling)
• Sutter Medical Center — Sacramento, California, United States (enrolling)
• University of California at San Francisco — San Francisco, California, United States (enrolling)
• Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Shands at the University of Florida — Gainesville, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Piedmont Augusta Hospital — Augusta, Georgia, United States (enrolling)
• WellStar Kennestone Hospital — Marietta, Georgia, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Advocate Health & Hospitals Corporation — Oakbrook Terrace, Illinois, United States (enrolling)
• St. Vincent Hospital — Indianapolis, Indiana, United States (enrolling)
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (enrolling)
• Kansas University Medical Center — Kansas City, Kansas, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• Norton Hospital — Louisville, Kentucky, United States (enrolling)
• Maine Medical Center — Portland, Maine, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Spectrum Health Butterworth Hospital — Grand Rapids, Michigan, United States (enrolling)
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• St. Luke's Hospital — Kansas City, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Banner-University Medical Center Phoenix — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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