Valve Heart DiseaseNCT04938960
Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material
An observational study of Valve Heart Disease, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Valve Heart Disease
- What is being tested?
- blood draw
- How many people
- 197 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2021to 5 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult males and females who will receive either a mechanical or biological heart valve implant
Who may be able to join
- patients who will receive either a biological or mechanical heart valve
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
Protein G HP SpinTrap columns will be used to capture IgG antibodies from patient serum pre-implant, between 2 weeks-3 months, between 3-11 months and between 12-18 months post-implant. These antibodies will be cross-linked to the column and then protein extracted from implant tissue (ie Native bovine/porcine pericardium) will be deglycosylated and run through the column. Antigenic proteins will be trapped and non-antigenic proteins will be washed through the column. These antigenic proteins will be eluted off the column and identified using LC-MS/MS. The proteins identified in the pre-implant elutant will be compared to the proteins in post-implant elutant to identify xenoantigens. Success criteria will be method validation by identification of previously known and new currently unknown xenoantigens.
- Conditions
- Valve Heart Disease
- Being tested
- blood draw
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Biological Heart Valve | Participants receiving a biological heart valve Receives: Diagnostic Test: blood draw | |
| Mechanical Heart Valve | Participants receiving a mechanical heart valve Receives: Diagnostic Test: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 12-18 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jul 2021
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leigh G. Griffiths, Mayo Clinic
- Investigators
- Leigh G Griffiths, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938960
- Sponsor's protocol ID
- 17-007803
- Status last verified
- May 2025
- First submitted
- 22 Jun 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material
- ClinicalTrials.gov ID
- NCT04938960
- Acronym / sponsor ID
- 17-007803
- Conditions
- Valve Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Protein G HP SpinTrap columns will be used to capture IgG antibodies from patient serum pre-implant, between 2 weeks-3 months, between 3-11 months and between 12-18 months post-implant. These antibodies will be cross-linked to the column and then protein extracted from implant tissue (ie Native bovine/porcine pericardium) will be deglycosylated and run through the column. Antigenic proteins will be trapped and non-antigenic proteins will be washed through the column. These antigenic proteins will be eluted off the column and identified using LC-MS/MS. The proteins identified in the pre-implant elutant will be compared to the proteins in post-implant elutant to identify xenoantigens. Success criteria will be method validation by identification of previously known and new currently unknown xenoantigens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological Heart Valve | – | Diagnostic Test: blood drawParticipants receiving a biological heart valve |
| Mechanical Heart Valve | – | Diagnostic Test: blood drawParticipants receiving a mechanical heart valve |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males and females who will receive either a mechanical or biological heart valve implant
Key inclusion criteria (1 listed)
- patients who will receive either a biological or mechanical heart valve
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawblood 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. | Diagnostic test | Biological Heart Valve, Mechanical Heart Valve |
Primary outcome
Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant.
Time frame: Approximately 12-18 months post-operatively
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
Related trials for Valve Heart Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh G Griffiths, PhD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valve Heart Disease, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant. (time frame: Approximately 12-18 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.