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Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair

Random, Controlled, Single-blinded, Multi-center and Non-inferiority Clinical Study to Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair

NCT03176225•LeMaitre Vascular

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

Detailed Description

Eligibility

Age

0 - 6 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Man or woman aged below 6 years old
•2. The expected lifetime of no less than 12 months
•3. Patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair.
•4. Physical conditions and vital signs meet requirements for the surgery.
•5. The subjects and/or their guardians sign the written Informed Consent Form.

Exclusion Criteria

•1. Patients with severe visceral diseases in liver, kidney, etc.
•2. Patients have unstable vital signs and not suitable for the indications.
•3. Patients with severe allergic history (especially allergic to bovine materials)
•4. Patients with the past medical history of severe immunodeficiency disease
•5. The subject has used or plans to use immunomodulatory drugs for more than half a year.
•6. The subject with poor blood clotting function, which is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100\*10\^9/L.
•7. The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate \[GRF\]\<30mL/min/1.73m2.
•8. The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus.
•9. The subject has participated in another clinical study within past 3 months or is participating in another clinical study now.
•10. The investigator believes that the subject has other reasons unsuitable for inclusion.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 15, 2017

Primary Completion Date

November 15, 2020

Completion Date

February 15, 2024

Last Updated

March 10, 2025

Enrollment

142

ACTUAL participants

Conditions

Heart Diseases

Interventions

Open heart surgery to address the heart disease

PROCEDURE

Close the defects with XenoSure Patch

DEVICE

Close the defects with Chest Polyester Patch

DEVICE

Lumason® Infusion vs. Bolus Administrations

NCT06400004

Heart Diseases

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RECRUITINGNA

Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

NCT06788275

Percutaneous Coronary Intervention (PCI)Acute Myocardial Infarction+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair

Inclusion Criteria

Exclusion Criteria

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