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: Â 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: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
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  Â
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 Â Â
Other Study ID Numbers:
2015-073
First Posted:
December 5, 2022 Â Â 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.
