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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05637242
• Other study ID #: 2015-073
• Status: Terminated
• Start date: February 2016
• Est. completion date: May 29, 2024

Study information

• Verified date: June 2024
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 371
• Est. completion date: May 29, 2024
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Frederik Meijer Heart Center	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One year mortality	Mortality will be assessed yearly.	One year
Secondary	Cytokine Analysis		Pre-implant, within 24 hours of implant, and 7 days post-implant
Secondary	Inflammatory cell subtype		Pre-implant, within 24 hours of implant, and 7 days post-implant
Secondary	Hospital readmissions		Will be assessed yearly until death or explant