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Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study

Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05637242
Enrollment
371
Registered
2022-12-05
Start date
2016-02-29
Completion date
2024-05-29
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Ventricular Assist Device

Brief summary

This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create algorithms to estimate the prognosis for patients getting a VAD.

Detailed description

Patients eligible for VAD are being sampled before surgery for plasma as well as peripheral blood cells. After surgery patients are being sampled again at 24 h and 7 days. Inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.

Interventions

None listed

Sponsors

Corewell Health West
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Subject is ≥ 18 years of age 2. Subject is treated with a VAD at the Butterworth Campus, Spectrum Health.

Exclusion criteria

1. Subject is less than 18 years of age. 2. Known prisoners of the state. 3. Subject is pregnant. 4. Non- English speaking patients will be excluded from the blood sub-study

Design outcomes

Primary

MeasureTime frameDescription
One year mortalityOne yearMortality will be assessed yearly.

Secondary

MeasureTime frame
Cytokine AnalysisPre-implant, within 24 hours of implant, and 7 days post-implant
Inflammatory cell subtypePre-implant, within 24 hours of implant, and 7 days post-implant
Hospital readmissionsWill be assessed yearly until death or explant

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026