TEAM-HF
Clinical Trial

Eligibility Criteria*

Key Inclusion Criteria

• New York Heart Association (NYHA) functional classification of IIIB or IV (NYHA Class IV included only in certain geographies)
• Left ventricular ejection fraction ≤30%
• Cardiac index ≤2.5 L/min/m²
• Limited functional status as demonstrated by a 6-minute walk distance test ≤350 m dueto heart failure-related reasons OR peak VO₂ ≤14 mL/kg/min (or <50% of predicted peak VO₂ value)
• One or more heart failure hospitalizations in the last 12 months
• Implanted CardioMEMS™ PA sensor or willingness to undergo a CardioMEMS PA sensor implant

Key Exclusion Criteria

• Dependent on IV inotrope in the last 30 days
• Existence of ongoing mechanical circulatory support
• Contraindications to HeartMate 3™ LVAD or CardioMEMS™ HF system
• History of any solid organ transplant
• Presence of an active, uncontrolled infection
• Complex congenital heart disease
• Planned ventricular assist device or biventricular assist device support prior to enrollment
• Any condition other than heart failure that could limit survival to less than 24 months

*Additional Inclusion and Exclusion Criteria are Listed on ClinicalTrials.gov (keywords "NCT06526195" and “TEAM-HF”)

Caution: Investigational device. Limited by federal (or U.S.) law to investigational use as part of the TEAM-HF trial.

CardioMEMS HF System Indications, Safety and Warnings

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.

CardioMEMS HF System Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

CardioMEMS HF System Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolism, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury or hemothorax.

HeartMate 3 LVAD Indications, Safety and Warnings

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
 

HeartMate 3™ Left Ventricular Assist System

Indications: The HeartMate 3™ Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.

Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or pump thrombosis.

HeartMate 3 Coring Tool

Indications: For the HeartMate 3 Left Ventricular Assist System (LVAS) Indications for Use, please refer to the HeartMate 3 LVAS Instructions for Use. The HeartMate 3™ Coring Tool is intended for use with the HeartMate 3 LVAS. The HeartMate 3 Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

Contraindications: The use of the HeartMate 3 Coring Tool is contraindicated in patients who are contraindicated for HeartMate 3 Left Ventricular Assist System (LVAS) therapy.

Adverse Events: The following adverse events may be associated with the use of the HeartMate 3 Coring Tool. Adverse events are listed in anticipated decreasing order of frequency, except for death, which appears first as it is a non-reversible complication: death, bleeding (perioperative or late), local infection, local ischemia, cardiac arrhythmia, stroke, peripheral thromboembolic event, neurologic dysfunction, hemolysis, sepsis.