HF Tissue Registry

NCT02683681 | Enrolling By Invitation

• 1 other identifier: 1009557
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a registry study. This is an observational, non-randomized, open, long-term project to collect biological samples (e.g. tissue and blood samples) in addition to clinical information and laboratory test results, from end-stage patients who undergo LVAD implantation and/or heart transplantation. There are no investigational treatments, drug or procedures associated with participation in registry activities. Data collection will not immediately influence the course of treatment for any patient.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  20 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are seen at participating facilities for left ventricular assist device (LVAD) implantation and/or heart transplantation will be screened for this registry study.

You may qualify if:

• Patients must be in one of the following groups:
• Patients must be eligible for a -
• LVAD implantation or
• Heart transplantation 1.2. Patients must be scheduled for another type of cardiac surgery during which tissue is excised that would normally be discarded after surgery.
• Patients must have a VAD already implanted as destination therapy with no cardiac surgery scheduled at the time of consent.
• Patients must agree to one or more blood and/or cardiac tissue sample donation(s), and longterm storage of these biological samples.
• Patients must be \> 18 years of age.

You may not qualify if:

• Patients will be excluded from the study if any of the following conditions are present:
• The patient or the patient's personal representative is unable or unwilling to give written informed consent for participation.
• Patients who are less than 18 years of age.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Drakos Lab, University of Utah Eccles Institute for Human Genetics: collaborator
• Center for Molecular and Genetic Research, LDS Hospital Cardiovascular Genetics Lab: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

* Tissue samples will be obtained at the time of LVAD implantation by keeping the part of the left ventricular apex that the surgeon is removing in order to place the inflow cannula of the LVAD. No extra tissue sample other than the tissue that has to be removed as a part of a standard LVAD operation needs to be obtained. * Tissue samples will be acquired from the failing heart at the time of heart transplantation, after it has been excised and a donor heart has been implanted in its place. * Control tissue samples will be acquired intraoperatively during cardiac surgery wherein any amount of excised tissue is routinely discarded.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Study Start: June 1, 2008
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2036
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share