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

Sponsor
Spectrum Health Hospitals (Other)
Overall Status
Recruiting
CT.gov ID
NCT05637242
Collaborator
Van Andel Research Institute (Other)
750
Enrollment
1
Location
108
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study
    Study Start Date :
    Feb 1, 2016
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. One year mortality [One year]

      Mortality will be assessed yearly.

    Secondary Outcome Measures

    1. Cytokine Analysis [Pre-implant, within 24 hours of implant, and 7 days post-implant]

    2. Inflammatory cell subtype [Pre-implant, within 24 hours of implant, and 7 days post-implant]

    3. Hospital readmissions [Will be assessed yearly until death or explant]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Frederik Meijer Heart Center Grand Rapids Michigan United States 49503

    Sponsors and Collaborators

    • Spectrum Health Hospitals
    • Van Andel Research Institute

    Investigators

    • Principal Investigator: Stefan Jovinge, MD PhD, The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Intstiture, Spectrum Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Renzo Loyaga Rendon, Renzo Loyaga Rendon MD, Spectrum Health Hospitals
    ClinicalTrials.gov Identifier:
    NCT05637242
    Other Study ID Numbers:
    • 2015-073
    First Posted:
    Dec 5, 2022
    Last Update Posted:
    Dec 5, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Renzo Loyaga Rendon, Renzo Loyaga Rendon MD, Spectrum Health Hospitals
    Ventricular Assist Device
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Dec 5, 2022