What we are studying

Almost all cardiac pacemarkers and defibrillators (ICDs) use a wire to conduct electricity to a patient's heart. The innovative WiSE CRT System, developed by EBR Systems, Inc., does not have any wires. A small electrode is implanted on the inside of the heart, and a special pacing system wirelessly sends impluses to this electrode to help pace the heart. Your regular pacemaker/ICD paces one side of your heart, and the WiSE System paces the other.

This is a single-arm study. You will receive the investigational device (WiSE System). 

Why it is important

Cardiac Resynchronization Therapy (CRT) has helped improve the lives of millions of people suffering from heart failure (HF) around the world. This is made possible by pacing both sides of the heart, instead of just one side that regular pacemakers/ICDs usually treat.

Some patients, however, either do not respond well to CRT (for example, their heart's function doesn't improve), or cannot have a CRT device placed for other reasons. That's where SOLVE-CRT steps in. SOLVE-CRT aims to test the WiSE CRT System in patients for whom regular CRT treatments have been unsuccessful.

What we hope to accomplish

We are hoping to gather enough data for the FDA to approve this device for commercial use. The WiSE System has been successfully tested outside the United States (as part of the SELECT-LV trial in Europe) and the results have been generally positive, so we are trying to bring this therapy to patients in the USA.