NCT07098858Recruiting
The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)
EBR Systems, Inc.
Start Date
11/3/2025
Completion Date
9/30/2032
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
Detailed 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 Criteria
Age Range: No minimum to No maximum
* 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
DEVICE
The Wise System
Conditions
Heart Failure
Locations
Arrhythmia Research Group (St. Bernards Hospital)
Jonesboro, Arkansas 72404
United States
Naples Community Hospital
Naples, Florida 34102
United States
University of Michigan
Ann Arbor, Michigan 48107
United States
Weill Cornell Medicine
New York, New York 10021
United States
Penn State Health
Hershey, Pennsylvania 17033
United States