The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)
EBR Systems, Inc.
Summary
Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
Description
The WiSE-UP Registry is a prospective, real-world, observational study aimed at understanding acute and long-term product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
* Patient or legally authorized representative can provide written authorization and/or consent per institution requirements. * Patient is intended to receive a WiSE System and passed the acoustic window screening * Patient who is, or will be, accessible for follow-up. * Participation is not excluded by local law. * Patient is not enrolled in a concurrent drug and/or device study that may confound the Registry results. * Patient life expectancy \>1 year.
Interventions
- DeviceThe Wise System
The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing.
Locations (5)
- Arrhythmia Research Group (St. Bernards Hospital)Jonesboro, Arkansas
- Naples Community HospitalNaples, Florida
- University of MichiganAnn Arbor, Michigan
- Weill Cornell MedicineNew York, New York
- Penn State HealthHershey, Pennsylvania