SOLVE CRT Study: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy (CRT) in Non-Responders and Previously Untreatable Patients

IRB Protocol #: 1708018442

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:  

• Be greater than 18
• Have been diagnosed with class I or IIa indication for an implantation of a CRT-D device and have been diagnosed as a non-responder. Have a CRT system and attempts at optimal device programming that has not responded for a minimum of 6 months
• Have been diagnosed as untreatable with a full or partial CRT system implanted
• Must be in sinus rhythm

Patients cannot participate if they have:

• Been diagnosed with right bundle branch block (RBBB)
• Been diagnosed with NYHA class IV
• Been diagnosed with contraindication to heparin, chronic anticoagulants or antiplatelet agents
• Chronic dialysis
• Been implanted with mechanical aortic valves or TAVR valves
• Been diagnosed with persistent or permanent atrial arrhythmias or have received a cardioversion for atrial fibrillation within the past month
• A drug or alcohol addiction

NCT02922036

Contact:

Dr. James Ip
Principle Investigator
Email: jei9008@med.cornell.edu
Phone: (212)746-2158

Rosa Chu
Research Coordinator
Email: roc2025@med.cornell.edu
Phone: (212) 746-4857