Ventricular Assist Device (VAD) Research Registry and Blo... | NCT05637242

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

NCT05637242

Sponsor

Corewell Health West

Status

Terminated

Last Update Posted

Jun 5, 2024Actual

Enrollment

371Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not able to achieve primary objective and there is no intention to work towards its achievement

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Oct 13, 2021Actual

Completion Date

May 29, 2024Actual

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Nov 23, 2022

First Posted Date

Dec 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2024

Last Update Posted Date

Jun 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

371Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One year mortality	Mortality will be assessed yearly.	One year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients being implanted with a ventricular assist device.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Renzo Loyaga, MD PhD	The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Institute, Corewell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frederik Meijer Heart Center		Grand Rapids	Michigan	49503	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases