RecruitingNCT07098858

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


Sponsor

EBR Systems, Inc.

Enrollment

320 participants

Start Date

Nov 3, 2025

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Inclusion Criteria6

  • 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.

Interventions

DEVICEThe 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.


Locations(5)

Arrhythmia Research Group (St. Bernards Hospital)

Jonesboro, Arkansas, United States

Naples Community Hospital

Naples, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Weill Cornell Medicine

New York, New York, United States

Penn State Health

Hershey, Pennsylvania, United States

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NCT07098858


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