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

NCT03176225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-03-10

No results posted yet for this study

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

Interventions

PROCEDURE

Open heart surgery to address the heart disease

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

DEVICE

Close the defects with XenoSure Patch

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

DEVICE

Close the defects with Chest Polyester Patch

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.

Sponsors & Collaborators

  • LeMaitre Vascular

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2020-11-15
Completion
2024-02-15
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176225 on ClinicalTrials.gov