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

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05637242

Recruitment Status : **RECRUITING NOW**
First Posted : December 5, 2022
Last Update Posted : December 5, 2022

Sponsor:

Collaborator:

Information provided by (Responsible Party):
Renzo Loyaga Rendon, Spectrum Health Hospitals

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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.

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.

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Study Type :
Observational [Patient Registry]

Estimated Enrollment :
750 participants

Observational Model:
Cohort

Time Perspective:
Other

Target Follow-Up Duration:
10 Years

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

Study Start Date :
February 2016

Estimated Primary Completion Date :
February 2024

Estimated Study Completion Date :
February 2025

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Primary Outcome Measures :

One year mortality [ Time Frame: One year ]
Mortality will be assessed yearly.

Secondary Outcome Measures :

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 ]

Biospecimen Retention:   Samples With DNABiospecimen retained include blood and serum.

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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:  
18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

Sampling Method:  
Non-Probability Sample

Patients being implanted with a ventricular assist device.

Inclusion Criteria:

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

Exclusion Criteria:

Subject is less than 18 years of age.
Known prisoners of the state.
Subject is pregnant.
Non- English speaking patients will be excluded from the blood sub-study

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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637242

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Frederik Meijer Heart Center

Grand Rapids, Michigan, United States, 49503

Contact: Jennifer I Schuitema, MA    616-391-6660    jennifer.schuitema@spectrumhealth.org   

Spectrum Health Hospitals
Van Andel Research Institute

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

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Responsible Party:
Renzo Loyaga Rendon, Renzo Loyaga Rendon MD, Spectrum Health Hospitals

ClinicalTrials.gov Identifier:
NCT05637242    

Other Study ID Numbers:
2015-073

First Posted:
December 5, 2022    Key Record Dates

Last Update Posted:
December 5, 2022

Last Verified:
November 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:
No

Keywords provided by Renzo Loyaga Rendon, Spectrum Health Hospitals:

Ventricular Assist Device

Additional relevant MeSH terms:

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Heart FailureHeart DiseasesCardiovascular Diseases

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

December 6, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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