Last reviewed · How we verify
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
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.
Details
| Lead sponsor | LeMaitre Vascular |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 142 |
| Start date | Tue Aug 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Heart Diseases
Interventions
- Open heart surgery to address the heart disease
- Close the defects with XenoSure Patch
- Close the defects with Chest Polyester Patch
Countries
China