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

Part of paid clinical trials in Mesa, Arizona.

Sponsor
EBR Systems, Inc.
Study ID
NCT07098858
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

First listed
Aug 1, 2025
Start date
Nov 3, 2025
Status verified
Sep 2026
Primary completion
Sep 30, 2032
Completion
Sep 30, 2032

Study Design

Enrollment
320 participants (estimated)

Arms

  • Arm: Single-arm, prospective, multicenter, observational study.
    Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible.

Primary Outcome Measure

Primary Safety [ Time Frame: 1, 6, 12, 24, 48 and 60 months ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
CardioVascular Associates of Mesa (CVAM)MesaArizona85206
Ambrose Panico, DO (PRINCIPAL_INVESTIGATOR)
Honor HealthScottsdaleArizona85258
Kathrina Spencer
[email protected]
Rahul N. Doshi, MD (PRINCIPAL_INVESTIGATOR)
Arrhythmia Research Group (St. Bernards Hospital)JonesboroArkansas72404
Kayla Rubino
[email protected]
Devi Nair, MD (PRINCIPAL_INVESTIGATOR)
Naples Community HospitalNaplesFlorida34102
Linda Pastorious
[email protected]
Dinesh Sharma, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48107
Jackson Liang, DO (PRINCIPAL_INVESTIGATOR)
St. Luke's Hospital of Kansas CityKansas CityMissouri64111
Susan Ehlert
[email protected]
Daniel Steinhaus, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10021
Ruwanthi J Perera
[email protected]
James IP, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Danielle Liggett
[email protected]
Niraj Varma, MD (PRINCIPAL_INVESTIGATOR)
Penn State HealthHersheyPennsylvania17033
Soraya Sami, MD (PRINCIPAL_INVESTIGATOR)
MUSCCharlestonSouth Carolina29245
Krista Szymanski
[email protected]
Anne Kroman, DO (PRINCIPAL_INVESTIGATOR)
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705
Deb Cardinal
[email protected]
J.David Burkhardt, MD (PRINCIPAL_INVESTIGATOR)
UVACharlottesvilleVirginia22903
Abbey Ferguson
[email protected]
Kenneth Bilchick, MD (PRINCIPAL_INVESTIGATOR)

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By research site
CardioVascular Associates of Mesa (CVAM)· Mesa, AZHonor Health· Scottsdale, AZArrhythmia Research Group (St. Bernards Hospital)· Jonesboro, ARNaples Community Hospital· Naples, FLUniversity of Michigan· Ann Arbor, MISt. Luke's Hospital of Kansas City· Kansas City, MO

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