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

NCT07098858 | Recruiting DMC FDA Device

• 1 other identifier: CSP-10005
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Primary Safety

  The primary outcome measure of the Registry is the rate of serious adverse events (SAEs) at \< 30 days post implant related to the WiSE System and/or implant procedure.

  1, 6, 12, 24, 48 and 60 months

Secondary Outcomes (11)

• Efficacy 1

  1 month

• Efficacy 2

  1 month

• Efficacy 3

  6 months

• Efficacy 4

  6 months

• Efficacy 5

  1, 6, 12, 24, 48 and 60 months

Study Arms (1)

Single-arm, prospective, multicenter, observational study.

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

Device: The Wise System

Interventions

The Wise System DEVICE

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.

Single-arm, prospective, multicenter, observational study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 320 patients will be enrolled in the registry and followed for five years.

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• EBR Systems, Inc.: lead

Study Sites (5)

Arrhythmia Research Group (St. Bernards Hospital)

Jonesboro, Arkansas, 72404, United States

RECRUITING

Naples Community Hospital

Naples, Florida, 34102, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48107, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Penn State Health

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jamie Burke

CONTACT

17194644185; clinical@ebrwise.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 1, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): September 30, 2032
• Study Completion (Estimated): September 30, 2032
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (5)