RecruitingRecruiting
The WiSE®-UP Study (The WiSE System Utilization & Performance Study)
NCT07098858 · EBR Systems, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The WiSE-UP Study 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
* 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.
Study design
Enrollment target: 320 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-11-03
Estimated completion: 2032-09-30
Last updated: 2026-09-10
Interventions
Device: The Wise System
Primary outcomes
- • Primary Safety (1, 6, 12, 24, 48 and 60 months)
Sponsor
EBR Systems, Inc. · industry
Contacts & investigators
ContactJamie Burke · contact · clinical@ebrwise.com · 17194644185
All locations (12)
CardioVascular Associates of Mesa (CVAM)Not Yet Recruiting
Mesa, Arizona, United States
Honor HealthRecruiting
Scottsdale, Arizona, United States
Arrhythmia Research Group (St. Bernards Hospital)Recruiting
Jonesboro, Arkansas, United States
Naples Community HospitalRecruiting
Naples, Florida, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
St. Luke's Hospital of Kansas CityRecruiting
Kansas City, Missouri, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Penn State HealthRecruiting
Hershey, Pennsylvania, United States
MUSCRecruiting
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research FoundationRecruiting
Austin, Texas, United States
UVARecruiting
Charlottesville, Virginia, United States