NCT07098858

The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 320 (estimated)
• Sponsor: EBR Systems, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	The Wise System	The 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.

Timeline

• Start date: 2025-11-03
• Primary completion: 2032-09-30
• Completion: 2032-09-30
• First posted: 2025-08-01
• Last updated: 2026-02-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study