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

Plain Language Summary

Simplified for easier understanding

This is a registry study — meaning it collects real-world data rather than testing a new treatment — following patients who receive the WiSE System, a wireless implantable pacemaker that delivers electrical signals directly to the left side of the heart. The goal is to track how well the device works in routine clinical practice. **You may be eligible if...** - Your doctor has decided that the WiSE pacemaker system is the right device for your heart condition - You passed the acoustic window screening required for the device to work - You or your legal representative can provide written consent - You are available for follow-up visits - Your life expectancy is more than 1 year - You are not currently in another drug or device study that might affect the results **You may NOT be eligible if...** - You are in a conflicting concurrent clinical study - You are not accessible for follow-up care - Local laws prevent your participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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