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.
Patient Journey
1
Informed Consent
Informed consent must be obtained from each subject prior to participation in the clinical investigation.
2
Baseline Data Collection
Eligible subjects will undergo an enrollment visit to collect baseline data.
3
CardioMEMS™ HF System Implant (If Applicable)
CardioMEMS™ PA sensor implantation procedure will be performed for subjects who are not already implanted with a CardioMEMS PA sensor.
4
Randomization
Subjects will be randomized in a 1:1 ratio between the HeartMate™ 3 LVAD or continued GDMT.
5
HeartMate 3 LVAD Implant
HeartMate 3 LVAD implantation procedure will be performed for subjects who are randomized to the HeartMate 3 LVAD group.
6
3-Month Follow-Up Visit
Subjects implanted with a HeartMate 3 LVAD will complete a follow-up visit 3 months post-procedure.
7
6-Month Follow-Up Visit
All randomized subjects will complete a 6-month follow-up visit.
8
12-Month Follow-Up Visit
All subjects will complete a 12-month follow-up visit.
9
Annual Follow-Up Visit Through 5 Years
All subjects will complete an annual follow-up visit at 2 through 5 years.
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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