
About the TEAM-HF Clinical Trial
The TEAM-HF clinical trial will gather scientific data focusing on the timing of treatments of heart failure (HF) patients by providing treatments before a patients’ heart failure gets worse, and when patients may need therapies beyond medications. The study will investigate if starting treatment with the HeartMate 3™ LVAD (a heart pump) earlier can show improvement in life expectancy and quality of life.
In addition, the trial will help determine whether pulmonary artery pressure monitoring with the CardioMEMS™ HF System can identify those who are at risk for worsening HF.
Approximately 500 patients in 75 medical centers globally will be studied. Half the patients will be randomly assigned to receive a HeartMate 3 LVAD, and the other half will be assigned to standard medical therapy. A qualified team of doctors will monitor patients included in the TEAM-HF Clinical Trial throughout the study.
Participants will play an important role in helping doctors evaluate the use of the CardioMEMS HF System and the HeartMate 3 LVAD for patients with heart failure.
What is Heart Failure?
Heart failure is when the heart has become too weak to pump blood and support your body.1 Your doctor may refer to heart failure as a ‘weak heart’. Symptoms of heart failure include, but are not limited to:2
Tiredness or Fatigue
Constant Coughing
Lightheadedness and Confusion
Trouble Breathing
Swelling
Weight Gain
Faster Heart Rate
Nausea or Lack of Appetite
Symptoms like these can limit your activities and way of life. They may also mean your heart failure is getting worse.
What Are the Stages of Heart Failure?
The New York Heart Association (NYHA) uses ‘classes’ or a heart failure class system to define the seriousness of heart failure and how it progresses over time.3
The descriptions above, developed by the NYHA, show each stage and how the related symptoms affect quality of life.
You can use this tool to:
What are the Treatment Options?
Your doctor will recommend the best treatment for you. There are various treatment options for heart failure, including medications, implantable cardioverter defibrillator, cardiac resynchronization therapy, mitral valve repair, pulmonary artery pressure monitoring and left ventricular assist devices.
The CardioMEMS HF System monitors the pressure in your pulmonary artery remotely so your doctor can see any changes and make simple adjustments to your care.
Once you are identified as a candidate for the CardioMEMS HF System, you will be scheduled for an implant. During the surgical procedure, the CardioMEMS™ Pulmonary Artery (PA) Sensor is inserted into the pulmonary artery during a right heart catheterization.
As with any medical procedure, there are risks associated with implanting the device, although complications are very rare.
An LVAD is a small device that helps pump the blood through the body.
1. HeartMate 3 LVAD
Connects to the left side of the heart and moves oxygenated blood from the left ventricle to the rest of the body.
2. System Controller
Powers and controls the LVAD and is small enough to fit in a pocket. Includes emergency battery backup.
3. Batteries
Provides up to 17 hours of uninterrupted power.
4. Modular Driveline
Facilitates simple replacement of externalized portion. Connects the heart pump to the system controller.
5. Mobile Power Unit
Plugs into an electrical outlet to provide power while indoors, at rest or asleep. Small, lightweight and mobile, the unit is designed to be extremely durable.
For any questions or concerns you may have regarding the medical procedures, devices and/or your personal health, please discuss these with your physician.
Are you a candidate for the TEAM-HF Trial?
You may qualify if:
What is involved if I choose to participate?
Before you are enrolled, your doctor and advanced heart failure team will assess your heart function to make sure your health status qualifies you for the clinical trial.
The first part of the trial will include implantation of the CardioMEMS HF System (if you do not already have one) so that your advanced heart failure team can monitor your pulmonary artery pressure and assess your heart function. If your pressure remains high despite optimal use of medications for at least 90 days, you may be eligible for the next step, randomization.
If you meet all the requirements, you will be randomized (like flipping a coin) to one of two groups. A computer program will randomly decide which group you will be in. Both groups will keep getting treated with medicine and having their pressures checked. You and your doctors cannot choose which group you will be assigned to.
People with advanced heart failure are usually treated with medicine first. However, some patients treated with medicine will still get worse over time. It is hard to know how sick people with heart failure really are because different people show symptoms in different ways.
The TEAM-HF trial wants to find out if there are other ways to know when you might benefit from more than just medications for your heart failure treatment. The study will also find out if an implanted device that pumps blood called the HeartMate 3 LVAD is helpful to treat your heart failure if you are given it sooner.
This research study includes a screening/qualification phase to determine if you are a good candidate for the study. Your trial doctor or other study personnel will ask you medically related questions. Additional tests will be conducted to determine if you qualify for the study. These evaluations will include a physical exam (i.e. height, weight, blood pressure, heart function) and blood test (needle stick to a vein in the arm to withdraw blood).
If you qualify and don’t already have a CardioMEMS™ Pulmonary Artery (PA) Sensor, one will be implanted to take part in this trial. The data obtained from your CardioMEMS HF System will be used by your doctor to adjust your medications.
Once all these tests have been completed, your trial doctor will decide if you qualify to take part in the next phase of the TEAM-HF study and you’ll be assigned to a group (arm). If you do not qualify for the next phase of the study, your participation will end.
The TEAM-HF trial is a randomized controlled trial. This means that if you qualify for the study, you will not have a choice in which treatment group you are assigned.
Randomization is the process by which you will be randomly (by chance) assigned to either of two groups (control group: Medications, or treatment group: HeartMate 3 LVAD). Randomization is like a coin toss in deciding which group you will be part of. A computer program will decide which group you will be in and you will have equal chance of being assigned to the control group or to the treatment group.
Due to the nature of the treatment, both you and your doctor will know which group you are assigned once you have been randomized.
If you are assigned to the control group, your medical team will continue adjusting your medications based on the pressures from your CardioMEMS PA sensor implant as you take your daily readings.
If you are assigned to the treatment group, you will be implanted with a HeartMate 3 LVAD in addition to the CardioMEMS HF System. Your medical team will be closely assessing your heart functions and your pressures by utilizing both devices.
If you are assigned to the treatment group, you will have surgery to implant the HeartMate 3 LVAD. One part of the pump will be attached to the bottom of your heart and another part will be attached to your aorta (a large blood vessel that carries blood from your heart to your body). A cable will go from the pump through the skin on your belly to a controller to power the pump. The pump can be powered by two batteries, or a mobile unit that is plugged into an AC wall outlet.
Being part of any research study comes with risks, discomforts, and difficulties. These risks can also affect an embryo, unborn child, or nursing infant if you become pregnant. It is important to think about these risks carefully. This study will have follow-up tests and procedures. The risks and side effects for each person can be different. Ask the study doctor if you have any questions.
Possible risks include, death, stroke, bleeding, infection. We do not know if the HeartMate 3 LVAD device will help you. There is a chance the HeartMate 3 LVAD could make your heart failure or your health worse.
Your study doctor will most likely ask you to start taking blood thinning medication after the implant procedure. This medication is important to prevent blood clots and for the HeartMate 3 LVAD to work properly.
Your doctor will discuss your treatment medications with you. Your medications will be customized to treat your heart failure by your medical team.
If you decide to participate in the trial, you will be managed by a study team which will include a cardiologist trained on the trial (if different from your cardiologist) and your regular cardiologist.
The two will work as a team to provide the best care for you.
You will receive available treatment for heart failure whether or not you take part in this trial.
Your doctor will discuss other treatment options with you if you decide not to join. Other options may include continuing to take medication to treat your heart condition or a heart transplant. One of your treatment options could still be the HeartMate 3 LVAD even if you decide not to join the study. Your doctor will explain in more detail the various alternative procedures or therapies available to you and the risks and benefits of these alternatives.
Your future care and your relationship with your doctor will not be affected if you decide not to be in this trial.
Caution: Investigational device. Limited by federal (or U.S.) law to investigational use as part of the TEAM-HF trial.
MAT-2415455 v1.0
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, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.
myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.
MAT-2006766 v6.0
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.
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.
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.
MAT-2012295 v3.0
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