NCT05637242

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

5.7 years

First QC Date

April 19, 2016

Last Update Submit

June 3, 2024

Conditions

Heart Failure

Keywords

Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

  • One year mortality

    Mortality will be assessed yearly.

    One year

Secondary Outcomes (3)

  • Cytokine Analysis

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

  • Inflammatory cell subtype

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

  • Hospital readmissions

    Will be assessed yearly until death or explant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being implanted with a ventricular assist device.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederik Meijer Heart Center

Grand Rapids, Michigan, 49503, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen retained include blood and serum.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Renzo Loyaga, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Renzo Loyaga Rendon MD

Study Record Dates

First Submitted

April 19, 2016

First Posted

December 5, 2022

Study Start

February 1, 2016

Primary Completion

October 13, 2021

Study Completion

May 29, 2024

Last Updated

June 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)