EBR Systems Achieves First Enrollments in the WiSE-UP Study for Heart Failure Patients
The WiSE-UP post-approval study is gathering real-world evidence from commercially treated patients using the WiSE® left ventricular endocardial pacing (LVEP) system.
Key Highlights:
- The first two patients have now been enrolled in the WiSE-UP post-approval study by Dr Devi Nair from St Bernards Heart & Vascular Center, Arkansas
- The EBR-sponsored study will evaluate real-world outcomes for heart failure patients receiving the FDA-approved WiSE® System for delivering LVEP in patients unable to receive traditional cardiac resynchronization therapy (CRT)
- The study will follow more than 300 patients across 50 US centers over a five-year period, and will generate both short- and long-term performance metrics
SUNNYVALE, Calif., Nov. 7, 2025 /PRNewswire/ -- EBR Systems, Inc., developer of the world's only wireless cardiac pacing system for heart failure, today announced the first patient enrollments in the WiSE® System Utilization & Performance (WiSE-UP) Study. The first two patients were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist.
This milestone marks an important step forward in advancing cardiac resynchronization therapy (CRT) for patients with heart failure with the addition of LVEP.
Sponsored by EBR Systems, the WiSE-UP Study is a prospective, observational post-approval study designed to evaluate real-world outcomes in patients treated with the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 patients across 50 centers over five years, generating both short- and long-term performance data to inform future clinical practice.
"It was an honor to lead the team performing the first WiSE System implant as part of the WiSE-UP Study," said Devi Nair, MD, FACC, FHRS, Electrophysiologist at St. Bernards Heart & Vascular Center. "Our entire team is proud to contribute to this important study, which we believe will further demonstrate the benefits of left ventricular endocardial pacing for patients with heart failure. We look forward to continuing our collaboration with EBR Systems as we work together to advance innovation in cardiac resynchronization therapy and improve patient outcomes."
Niraj Varma, MD, PhD, FRCP, Professor of Medicine at the Cleveland Clinic and the National Principal Investigator for the study said: "The launch of the WiSE-UP Study marks an exciting moment in cardiac resynchronization therapy. This study will evaluate the application of left ventricular endocardial pacing in real world practice, capture important clinical outcomes over time, and assess sustained therapeutic impact of the WiSE System. I am proud to lead this initiative that will continue to develop the standards of care for heart failure patients."
For more information about EBR, please visit https://www.ebrsystemsinc.com/.
About EBR Systems
EBR Systems is a cardiac rhythm management company on a clear mission: to transform the lives of people with heart failure by helping physicians deliver optimal cardiac pacing. The WiSE System—the first FDA approved system for leadless left ventricular endocardial pacing (LVEP) in CRT—combines advanced engineering with peer-reviewed clinical evidence to expand access for patients who previously lacked options and to improve outcomes.
About the WiSE Technology
The WiSE System delivers LV endocardial pacing without a transvenous LV lead using targeted ultrasound. A subcutaneous transmitter and battery detect the RV pacing signal and, within milliseconds, emit ultrasound energy that a rice-sized endocardial electrode converts into an electrical pulse—enabling synchronized biventricular pacing. This LVEP approach is engineered for versatility across patient anatomies and is supported by peer-reviewed outcomes from SOLVE-CRT pivotal trial. WiSE is approved for commercial use in the United States and limited to clinical study use outside of the United States.
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