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

NCT03176225 | Completed DMC FDA Device

• 1 other identifier: P15077-1
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Leakage rate at 6 month post-procedure measured by ultrasound

  The heart defects should be totally closed by the patch. Any residual flow or leakage, measured by ultrasound, will be recorded. The percentage of the patients that show leakage post-procedure is the failure rate. The study is considered achieved its primary endpoint if the failure rate of the test device is non-inferior to the rate of the comparator device.

  6 months

Study Arms (2)

Test Arm

EXPERIMENTAL

In Test Arm, the subjects will be implanted with test article - XenoSure patch. The interventions include: Open heart surgery to address the heart disease; Close the defects with XenoSure Patch

Procedure: Open heart surgery to address the heart disease; Device: Close the defects with XenoSure Patch

Control Arm

ACTIVE COMPARATOR

In Control Arm, the subjects will be implanted with comparator device - Polyester patch by Shanghai Chest Medical Technology Co. The interventions include: Open heart surgery to address the heart disease; Close the defects with Chest Polyester Patch

Procedure: Open heart surgery to address the heart disease; Device: Close the defects with Chest Polyester Patch

Interventions

Open heart surgery to address the heart disease PROCEDURE

The patient will first have open heart surgery to achieve access to the diseased site in the heart

Control Arm; Test Arm

Close the defects with XenoSure Patch DEVICE

The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.

Test Arm

Close the defects with Chest Polyester Patch DEVICE

The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with a Polyester Patch made by Shanghai Chest Medical Technology Co.

Control Arm

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patients with severe visceral diseases in liver, kidney, etc.
• Patients have unstable vital signs and not suitable for the indications.
• Patients with severe allergic history (especially allergic to bovine materials)
• Patients with the past medical history of severe immunodeficiency disease
• The subject has used or plans to use immunomodulatory drugs for more than half a year.
• 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.
• The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate \[GRF\]\<30mL/min/1.73m2.
• 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.
• The subject has participated in another clinical study within past 3 months or is participating in another clinical study now.

Sponsors & Collaborators

• LeMaitre Vascular: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: August 15, 2017
• Primary Completion: November 15, 2020
• Study Completion: February 15, 2024
• Last Updated: March 10, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)