NCT04178213

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Anteris Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Stenosis
• Aortic Insufficiency

Interventions

Type	Name	Description
DEVICE	Implantation of ADAPT 3D ALR	The operation is performed through a median sternotomy and with the hemodynamic support of standard cardiopulmonary bypass (CBP). diseased leaflets are excised meticulously. Calcifications at the level of the annulus will be removed just like in any other aortic valve replacement procedure. The annulus will be sized and the appropriate 3D single piece valve will be chosen. The implant technique will consist out of one running suture line at the level of the annulus, followed by fixation of the 3 commissural parts against the aortic wall. Valve competence and function will be assessed visually, and by TEE immediately coming of bypass.

Timeline

• Start date: 2020-03-26
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2019-11-26
• Last updated: 2022-02-16

Locations

1 site across 1 country: Belgium