The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)
Recruiting · NCT07098858 · Observational (researchers observe without assigning treatment) · Lead sponsor: EBR Systems, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
The Wise System
What this trial is about
Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Eligibility criteria (as published)
* 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.
Where it is running
5 locations listed across 5 US states.
- Arrhythmia Research Group (St. Bernards Hospital) - Jonesboro, Arkansas, United States
- Naples Community Hospital - Naples, Florida, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Weill Cornell Medicine - New York, New York, United States
- Penn State Health - Hershey, Pennsylvania, United States