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First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair

Aortic Stenosis Clinical Trial

Official title:
First in Human Surgical Implantation of Single Piece ADAPT® Treated 3D ALR (Aortic Leaflet Repair), Feasibility and Clinical Safety Study

Clinical Trial Summary

This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.

Clinical Trial Description

The purpose of this study is to conduct the initial clinical investigation of single piece ADAPT treated 3D - ALR (Aortic Leaflet Repair) to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical performance with significant improvements in clinical hemodynamic performance. The ADAPT® technology is used to process animal derived tissues to produce implantable tissue prosthetic devices that are compatible with the human body. This technology has been shown to produce reliable, biocompatible and versatile regenerative prosthetic devices capable of being used instead of synthetic products currently used in many soft tissue repair applications. 15 patients with aortic valve insufficiency or stenosis will be enrolled in this single arm single site study. Follow-up will continue through to 26 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04178213
Study type Interventional
Source Admedus Regen Pty Ltd.
Contact Factory CRO
Phone +31 30 229 2727
Email jurriaan.sombeek@avaniaclinical.com
Status Recruiting
Phase N/A
Start date March 26, 2020
Completion date June 2022
View Details
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