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NCT Number: NCT07098858

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

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

Recruiting

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Research Group (St. Bernards Hospital), Jonesboro, Arkansas, United States

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About this study

The WiSE-UP Registry is a prospective, real-world, observational study aimed at understanding acute and long-term product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Primary Safety

    Time frame: 1, 6, 12, 24, 48 and 60 months

    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.

Secondary outcomes

  1. Efficacy 1

    Time frame: 1 month

    Procedural Success of the Leadless LV endocardial pacing (LVEP)

  2. Efficacy 2

    Time frame: 1 month

    CRT response assessment of NYHA functional classification

  3. Efficacy 3

    Time frame: 6 months

    Left ventricular ejection fraction (LVEF)

  4. Efficacy 4

    Time frame: 6 months

    Left ventricular and systolic volume (LVESV)

  5. Efficacy 5

    Time frame: 1, 6, 12, 24, 48 and 60 months

    Heart failure clinical composite score (HF CCS) categorizing patients as improved, unchanged or worsened

  6. Efficacy 6

    Time frame: 1, 6, 12, 24, 48 and 60 months

    New York Heart Association (NYHA) classification values of Markedly improved, Moderately improved, Mild improvement, No change or Slightly worse

  7. Efficacy 7

    Time frame: 1, 6, 12, 24, 48 and 60 months

    QRS duration

  8. Efficacy 8

    Time frame: 6 and 12 months

    Minnesota Living with Heart Failure Questionnaire (MLHFQ) a validated tool designed to assess the impact of heart failure on a patient's quality of life

  9. Efficacy 9

    Time frame: 1, 6, 12, 24, 48 and 60 months

    Events assessment: confirmation of reportable events including updates to any previously reported events

  10. Efficacy 10

    Time frame: 1, 6, 12, 24, 48 and 60 months

    Mortality is based on an estimated 1-year rate of 10%- and 1-year attrition of up to 15%

  11. Efficacy 11

    Time frame: 1, 6, 12, 24, 48 and 60 months

    Patient global assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie Burke

CONTACT

[email protected]

17194644185

Sponsors and collaborators

Lead sponsor

EBR Systems, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Aug 1, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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