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

Terminated

• Conditions: Heart Failure

• Registration Number: NCT05637242
• Lead Sponsor: Spectrum Health Hospitals

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-19
• Primary Completion: 2021-10-13
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-05
• Study Completion: 2024-05-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 371

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One year mortality	One year	Mortality will be assessed yearly.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Frederik Meijer Heart Center; 🇺🇸 Grand Rapids, Michigan, United States