TEAM-HF Clinical Trial
The purpose of the TEAM-HF clinical trial is to evaluate the safety and effectiveness of the HeartMate 3™ Left Ventricular Assist Device (LVAD) compared to guideline-directed medical therapy (GDMT) in ambulatory advanced heart failure patients with refractory pulmonary hypertension who are not dependent on intravenous inotropes.
Refractory pulmonary hypertension, as determined by remote pulmonary artery pressure monitoring using the CardioMEMS™ HF System, will be utilized as an objective measure to identify patients at high risk of worsening heart failure.
CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use as part of the TEAM-HF trial.
Trial Design
This is prospective, randomized, open-label study of left ventricular assist device (LVAD) vs continued guideline directed medical therapy (GDMT) in non-inotrope dependent heart failure patients with refractory pulmonary hypertension secondary to left ventricular failure. The trial will randomize up to 500 patients at approximately 75 centers (~60 US-based centers and ~15 international centers).
The overall objectives of TEAM-HF trial are two-fold:
- 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
- To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT.
Subjects in this clinical investigation will be randomized between the HeartMate 3 LVAD and medical therapy in a 1:1 ratio.
To learn more about the TEAM-HF Trial, including eligibility criteria and study locations, please visit ClinicalTrials.gov website.
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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.
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