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TerminatedNCT05637242Updated Jun 5, 2024

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

An observational study in Heart Failure, sponsored by Spectrum Health Hospitals. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Spectrum Health Hospitals · Observational

Why this study was terminated
Study was not able to achieve primary objective and there is no intention to work towards its achievement
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
371
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Heart Failure

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Keywords

  • Ventricular Assist Device
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 371 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Spectrum Health Hospitals is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients being implanted with a ventricular assist device.

Inclusion criteria

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

Exclusion criteria

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

Observational model
Cohort
Time perspective
Other
Enrollment
371 participants (actual)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. One year mortality

    Mortality will be assessed yearly.

    Time frame: One year

Secondary outcomes

  1. Cytokine Analysis

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

  2. Inflammatory cell subtype

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

  3. Hospital readmissions

    Time frame: Will be assessed yearly until death or explant

07

Study locations

1 site
  • Frederik Meijer Heart Center
    Grand Rapids, Michigan 49503, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05637242
Lead sponsor
Spectrum Health Hospitals
Responsible party
Renzo Loyaga Rendon (Renzo Loyaga Rendon MD, Spectrum Health Hospitals) — Principal investigator
First posted
Dec 5, 2022
Start date
Feb 2016
Primary completion
Oct 13, 2021
Completion
May 29, 2024
Last update
Jun 5, 2024

Study contacts

Renzo Loyaga, MD PhD
principal investigator · The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Institute, Corewell Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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