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

NCT ID: NCT05637242

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

371 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2024-05-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Renzo Loyaga Rendon

Renzo Loyaga Rendon MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Renzo Loyaga, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Institute, Corewell Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Frederik Meijer Heart Center

Grand Rapids, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-073

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Corheart 6 LVAS Long-term Follow-up Study
NCT06267612 NOT_YET_RECRUITING NA