The BioVentrix Revivent TC™ System – A New Treatment Option for Your Heart Failure

STUDY BASICS

Have you been diagnosed with heart failure? If so, you may be able to participate in a research study using the BioVentrix Revivent TC™ System, an investigational device that may help improve heart function and reduce heart failure symptoms.

STUDY PURPOSE

Heart failure is a condition in which the heart muscle is weakened and cannot pump enough blood to the body. Most people with heart failure have permanent damage to the heart muscle, resulting in chest pain, shortness of breath, irregular heartbeat, and an increased risk of blood clots. The standard operation to repair damaged heart muscle involves complex procedures, including opening the chest and heart chamber and using a heart-lung machine. This type of surgery can sometimes lead to serious complications. The purpose of this study is to test an investigational device called BioVentrix Revivent TC™ System that uses tiny anchors implanted in the heart through a small incision. The anchors are used to isolate damaged heart muscle and allow the remaining healthy tissue to work more effectively. Researchers hope the use of the device will lead to an improvement in heart failure symptoms, while avoiding the complicated procedures used in standard operations.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-80
• Have symptoms of congestive heart failure
• Able to walk on a flat surface (even if only briefly)
• Not pregnant and not planning to become pregnant for at least one year following the procedure

WHAT PARTICIPANTS CAN EXPECT

For people who qualify for treatment with the investigational device, participation includes a screening visit, baseline visit, investigational device procedure and a visit at discharge, follow-up visits after 1, 6, and 12 months, and yearly follow-up for 5 years. Tests and assessments include blood draws, physical and cardiac exams, and others. If your doctors find that the investigational device is not right for you, or if you decide to not have the investigational device procedure, you will be asked to participate in a comparison group. This group will have all the same study visits and procedures, except for the investigational device procedure.