Heart tissue defects Q20-Q28
Conditions
Interventions
Group 1: Cardiac or vascular surgery for the expansion and/or repair of heart or Vascular Tissue Defects
Sponsors
Auto Tissue Berlin GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is to prospectively evaluate the safety of the equine matrix patch. Safety defined as rates of device and procedure related serious adverse events post-implantation of the Matrix Patch at 6 months post-implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes of this study are the evaluation of the usability and the performance of the equine matrix patches during cardiovascular surgery. 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. 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. | — |
Countries
Germany, Slovakia
Contacts
Public ContactHans-Joachim Schäfers
Klinik für Thorax- und Herz-Gefäßchirurgie Universitätsklinik Homburg
Outcome results
None listed