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

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT07098858
• Lead Sponsor: EBR Systems, Inc.

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-05
• Study Start: 2025-09-01
• Primary Completion: 2032-09-30
• Study Completion: 2032-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety	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 Outcome Measures

Name	Time	Method
Efficacy 1	1 month	Procedural Success of the Leadless LV endocardial pacing (LVEP)
Efficacy 2	1 month	CRT response assessment of NYHA functional classification
Efficacy 3	6 months	Left ventricular ejection fraction (LVEF)
Efficacy 4	6 months	Left ventricular and systolic volume (LVESV)
Efficacy 5	1, 6, 12, 24, 48 and 60 months	Heart failure clinical composite score (HF CCS) categorizing patients as improved, unchanged or worsened
Efficacy 6	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
Efficacy 7	1, 6, 12, 24, 48 and 60 months	QRS duration
Efficacy 8	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
Efficacy 9	1, 6, 12, 24, 48 and 60 months	Events assessment: confirmation of reportable events including updates to any previously reported events
Efficacy 10	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%
Efficacy 11	1, 6, 12, 24, 48 and 60 months	Patient global assessment