NCT02683681

HF Tissue Registry

Heart Failure Intraoperative Tissue Sample Acquisition Registry

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After informed consent is obtained from the patient, the blood samples will be obtained either during a procedure from access lines inserted for the procedure or they will be drawn when other ordered lab work is done at specific time points. While blood samples collection is preferred, it is not required, and the decision to collect blood samples will be left to the discretion of the investigator. * 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. In some cases, when a patient has an existing LVAD implant for destination therapy, and is not eligible for cardiac transplant, and is not scheduled for cardiac surgery in the foreseeable future, the patient will be approached for consent for blood samples. In addition, consent to obtain intraoperative tissue samples is requested in the event cardiac surgery occurs and/or the device is explanted for any reason in the future.

Conditions

• Heart Failure

Timeline

• Start date: 2008-06-01
• Primary completion: 2036-12-31
• Completion: 2036-12-31
• First posted: 2016-02-17
• Last updated: 2026-04-14