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

EBR Systems

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: The Wise System

Study type: Observational

Funder types: Industry

Identifiers

NCT07098858

CSP-10005

Details and patient eligibility

About

Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System

Full 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.

Enrollment: 320 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

320 participants in 1 patient group

Single-arm, prospective, multicenter, observational study.

Description:

Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible.

Treatment:

Device: The Wise System