Trials / Completed
CompletedNCT03176225
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- LeMaitre Vascular · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
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
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. There will be 144 subjects enrolled, including 72 subjects in the trial arm and 72 subjects in the control arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-08-15
- Primary completion
- 2020-11-15
- Completion
- 2024-02-15
- First posted
- 2017-06-05
- Last updated
- 2025-03-10
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03176225. Inclusion in this directory is not an endorsement.