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

NCT07098858 · tracked via the Priya Life Science USA tracker

Sponsor

EBR Systems, Inc.

Phase

Observational

Started

2025-11-03

Last updated

2026-09-10

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

The Wise System

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.

Study 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

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

* 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.

Primary outcome measure(s)

Primary Safety — 1, 6, 12, 24, 48 and 60 months
The primary outcome measure of the Study is the rate of serious adverse events (SAEs) at \< 30 days post implant related to the WiSE System and/or implant procedure.

Trial sites (12)

Facility	City	Region	Status
CardioVascular Associates of Mesa (CVAM)	Mesa	Arizona	Not Yet Recruiting
Honor Health	Scottsdale	Arizona	Recruiting
Arrhythmia Research Group (St. Bernards Hospital)	Jonesboro	Arkansas	Recruiting
Naples Community Hospital	Naples	Florida	Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
St. Luke's Hospital of Kansas City	Kansas City	Missouri	Recruiting
Weill Cornell Medicine	New York	New York	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Penn State Health	Hershey	Pennsylvania	Recruiting
MUSC	Charleston	South Carolina	Recruiting
Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	Recruiting
UVA	Charlottesville	Virginia	Recruiting

More EBR Systems, Inc. trials in the USA

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

Other trials for the same condition

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study) Enrolling by invitation

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure Recruiting

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07098858 on ClinicalTrials.gov ↗ ← All trials in the USA