The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)
Part of paid clinical trials in Jonesboro, Arkansas.
- Sponsor
- EBR Systems, Inc.
- Study ID
- NCT07098858
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- The Wise System — DEVICEThe 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.
Study Details
Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
Key Dates
- Start date
- Nov 3, 2025
- Status verified
- Feb 2026
- Primary completion
- Sep 30, 2032
- Completion
- Sep 30, 2032
Study Design
- Enrollment
- 320 participants (estimated)
Arms
- Arm: Single-arm, prospective, multicenter, observational study.Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible.
Primary Outcome Measure
Primary Safety [ Time Frame: 1, 6, 12, 24, 48 and 60 months ]
Central Contacts
- Jamie Burke17194644185
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arrhythmia Research Group (St. Bernards Hospital) | Jonesboro | Arkansas | 72404 | Kayla Rubino Devi Nair (PRINCIPAL_INVESTIGATOR) |
| Naples Community Hospital | Naples | Florida | 34102 | Linda Pastorious Dinesh Sharma (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48107 | Kirsta Bray Jackson Liang, MD (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medicine | New York | New York | 10021 | Ruwanthi J Perera James IP, MD (PRINCIPAL_INVESTIGATOR) |
| Penn State Health | Hershey | Pennsylvania | 17033 | LIsa Fox Soraya Sami, MD (PRINCIPAL_INVESTIGATOR) |
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