Heart Failure / The Wise System · Observational Study

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

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational registry study of the WiSE cardiac resynchronization device in heart failure patients. No results are reported in this registry record; the study is currently recruiting and will track safety, clinical outcomes, and CRT response over 60 months.

What was studied

Observational. Heart Failure; age from 22 Years. Intervention: Single-arm, prospective, multicenter, observational study.. n = 320. 12 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record describing a planned observational study with no results posted; it documents enrollment and design only.

Study design

As stated by the source record.

MethodsCase Control model. Prospective time perspective. Primary outcome measure: Primary Safety (assessed at 1, 6, 12, 24, 48 and 60 months)

DesignObservational

PopulationHeart Failure; age from 22 Years

Sample size320

InterventionSingle-arm, prospective, multicenter, observational study.

Setting12 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment320

Study typeObservational

Primary outcome measurePrimary Safety at 1, 6, 12, 24, 48, and 60 months

Recruitment statusRECRUITING

Caveats

No results are reported; this is a registry record only
Observational design without control or comparator
No baseline characteristics, inclusion/exclusion criteria, or outcome definitions provided in this record
Follow-up duration and statistical analysis plan not described

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational study without control arm or randomization

Directness

moderate

Safety and clinical outcomes directly measured; CRT response assessed

Consistency

insufficient

Single-arm registry study; no comparator or replication reported

Risk of bias

limited

Observational design without blinding or control; sponsor-led registry

Sample adequacy

moderate

Estimated 320 participants; adequate for observational safety surveillance

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07098858). This is a study registration, not published results. Lead sponsor: EBR Systems, Inc.. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DEVICE: The Wise System. Primary outcome measures: Primary Safety , 1, 6, 12, 24, 48 and 60 months. 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

EBR SystemsHeart FailureThe Wise SystemNCT07098858