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

NCT04938960 | Completed

• 1 other identifier: 17-007803
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant.

  The captured proteins will be identified, and compared over time (i.e., pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and 12-18 months post-operatively) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.

  Approximately 12-18 months post-operatively

Study Arms (2)

Biological Heart Valve

Participants receiving a biological heart valve

Diagnostic Test: blood draw

Mechanical Heart Valve

Participants receiving a mechanical heart valve

Diagnostic Test: blood draw

Interventions

blood draw DIAGNOSTIC_TEST

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.

Biological Heart Valve; Mechanical Heart Valve

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult males and females who will receive either a mechanical or biological heart valve implant

You may qualify if:

• patients who will receive either a biological or mechanical heart valve

You may not qualify if:

• Currently receiving therapy for cancer requiring treatment with concurrent radiotherapy and/or chemotherapy
• Cancer in remission for less than 5 years if previously treated with radiotherapy and/or chemotherapy
• Previous tissue valve implants
• Current pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Leigh G Griffiths, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)