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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure

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 Type: Observational
• Enrollment (Actual): 371

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Frederik Meijer Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients being implanted with a ventricular assist device.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One year mortality	Mortality will be assessed yearly.	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Cytokine Analysis	Pre-implant, within 24 hours of implant, and 7 days post-implant
Inflammatory cell subtype	Pre-implant, within 24 hours of implant, and 7 days post-implant
Hospital readmissions	Will be assessed yearly until death or explant

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Collaborators: Van Andel Research Institute
• Investigators: Principal Investigator: Renzo Loyaga, MD PhD, The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Institute, Corewell Health

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ventricular Assist Device
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2015-073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO