A Post-Market Clinical Follow-up Study of the Auto Tissue Berlin Equine Matrix Patch™:The All-Patch Study

Recruiting

• Conditions: Heart tissue defects; Q20-Q28; Congenital malformations of the circulatory system

• Registration Number: DRKS00023620
• Lead Sponsor: Auto Tissue Berlin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Diagnosed with cardiac or vascular disease for which surgical repair involving a tissue patch is indicated.

2. Written consent of the patient or the legal guardian.

Exclusion Criteria

1. Patients in whom the treating physician or surgeon believes that the risks of using a xenograft for repair of congenital or acquired cardiac or vascular tissue defects outweigh the benefits.

2. Patient is participating in an investigational drug or device study that has not reached the primary endpoint or that interferes with the current study endpoints.

3. Any condition that in the judgment of the investigators would interfere with the patient’s ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound interpretation of study results.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is to prospectively evaluate the safety of the equine matrix patch.<br>Safety defined as rates of device and procedure related serious adverse events post-implantation of the Matrix Patch at 6 months post-implantation.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes of this study are the evaluation of the usability and the performance of the equine matrix patches during cardiovascular surgery.<br><br>Usability: Defined as the satisfaction with and ease of use of the Matrix Patch as reported by the surgeon performing the surgery in which the Matrix Patch was used.<br><br>Performance: Defined as the incidence of repeat surgery to repair the abnormality for which the Matrix Patch was used, and the absence of adverse outcomes related to the Matrix Patch (including death) assessed at 1 year.