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

Corewell Health West371 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

371

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Frederik Meijer Heart Center

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

One year mortality

Mortality will be assessed yearly.

Time frame: One year

Secondary Outcomes

Cytokine Analysis

Time frame: Pre-implant, within 24 hours of implant, and 7 days post-implant

Inflammatory cell subtype

Time frame: Pre-implant, within 24 hours of implant, and 7 days post-implant

Hospital readmissions

Time frame: Will be assessed yearly until death or explant

Data from ClinicalTrials.gov

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