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Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material

NCT04938960 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 197

Last updated 2025-05-06

No results posted yet for this study

Summary

This study involves collecting serum samples from patients presenting for aortic valve replacement at Mayo Clinic, Rochester, MN. Serum samples will be collected pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and between 12-18 months post-operatively. The patients antibodies in these serum samples will be used to capture proteins from the same type of tissue their replacement heart valves are made from (i.e., bovine/porcine pericardium - a non-human tissue which is currently used to make glutaraldehyde-fixed heart valves). The captured proteins will be identified, and compared over time (i.e., 0, 1, 3 and 12 months) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.

Conditions

  • Valve Heart Disease

Interventions

DIAGNOSTIC_TEST

blood draw

blood will be drawn at pre-operation, between 2 weeks and 3 months, between 3-11 months (optional; we will collect a sample if the patient returns to Mayo Clinic for any other non-study related visit), and between 12-18 months post-operatively.

Sponsors & Collaborators

Principal Investigators

  • Leigh G Griffiths, PhD · Mayo Clinic

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-09-05
Completion
2024-09-05

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938960 on ClinicalTrials.gov