Clinical Trials Logo
  1. Home
  2. Valve Heart Disease
  3. NCT04938960

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

Valve Heart Disease Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04938960
Study type Observational
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase
Start date July 1, 2021
Completion date March 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT05079672 - Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery Phase 4
Completed NCT03347851 - Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Completed NCT04328090 - Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship N/A
Recruiting NCT04359030 - Freestyle-Perimount Calcification Comparison
Completed NCT04958668 - Prospective Evaluation of Volatile Sedation After Heart Valve Surgery N/A
Completed NCT04598360 - Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine) N/A
Not yet recruiting NCT04118621 - Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery
Recruiting NCT06387446 - Allogeneic Valve Transplantation N/A
Recruiting NCT04843072 - Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis N/A
Completed NCT05804500 - RecoveryPlus Telerehab Platform Pilot Study N/A
Recruiting NCT03885180 - Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy N/A
Completed NCT06154018 - Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass. N/A
Recruiting NCT06041308 - Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve
Suspended NCT01571791 - Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery Phase 2
Completed NCT06261788 - Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter N/A
Completed NCT06079008 - The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
Completed NCT04372654 - Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients N/A
Active, not recruiting NCT03661398 - Caisson Transcatheter Mitral Valve Replacement (TMVR) N/A