WiSE-UP Registry: tracking the WiSE heart-pacing system's performance
The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)
EBR Systems, Inc. · NCT07098858
This registry will track how the WiSE System works and affects safety and heart-failure outcomes in people who receive it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Sex | All |
| Sponsor | EBR Systems, Inc. (industry) |
| Locations | 5 sites (Jonesboro, Arkansas and 4 other locations) |
| Trial ID | NCT07098858 on ClinicalTrials.gov |
What this trial studies
The WiSE-UP Registry is a prospective, real-world, observational registry collecting short- and long-term data on the market-released WiSE leadless left-ventricular pacing system. It records patient safety events, clinical outcomes, and cardiac resynchronization therapy (CRT) response information in patients intended to receive the device. Eligible patients must pass an acoustic window screening, be available for follow-up, and not be in concurrent studies that would confound results. The registry is run at participating clinical centers in the United States and is sponsored by the device manufacturer to better characterize routine clinical use.
Who should consider this trial
Good fit: Ideal candidates are people with heart failure who are planned to receive the WiSE System, have passed the acoustic window screening, can complete follow-up, and have expected life expectancy greater than one year.
Not a fit: Patients who failed the acoustic window screening, have life expectancy of one year or less, or are enrolled in other conflicting drug or device trials are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help identify safety issues and clarify which patients are most likely to benefit from the WiSE System.
How similar studies have performed: Prior small feasibility studies and early registries of the WiSE System have reported promising CRT responses and safety signals, but larger real-world long-term data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jonesboro, Arkansas and 4 other locations
- Arrhythmia Research Group (St. Bernards Hospital) — Jonesboro, Arkansas, United States (RECRUITING)
- Naples Community Hospital — Naples, Florida, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Weill Cornell Medicine — New York, New York, United States (RECRUITING)
- Penn State Health — Hershey, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Jamie Burke
- Email: clinical@ebrwise.com
- Phone: 17194644185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure