Overview: The purpose of the study is to test a new way to pace the left side of the heart without using pacing leads, using the WiCS-LV System. A cardiac (heart) resynchronization therapy (CRT), is a device that regulates your heartbeat. A new type of system, called the WiCS-LV System, is a wireless cardiac stimulation system for the left ventricle intended to help reduce certain complications associated with traditional CRT devices. CRT therapy has been previously either been recommended, or has been implanted without improving your condition, or has been attempted to be implanted without success. It has not been approved for general use by the Food and Drug Administration (FDA), and its use in this study is considered investigational.
In this study, ultrasound will be used to transfer energy from a new type of pacemaker through your body to a special receiver that is placed inside the left ventricle of your heart. The receiver will use the ultrasound energy to pace the heart without using pacing leads.
This trial is funded by EBR Systems.
To be eligible, patients must:
Patients cannot participate if they have: