NCT02629328

CardioCel Tri-leaflet Repair Study

CardioCel Tri-leaflet Repair Study; a Prospective, Non-randomised, Single Arm, Multi-centre Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Anteris Technologies Ltd. · Industry
• Sex: All
• Age: 85 Years
• Healthy volunteers: Not accepted

Summary

This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.

Detailed description

The purpose of this study is to evaluate the safety and efficacy of the CardioCel for the repair of aortic valve stenosis and/or insufficiency. CardioCel is a cardiovascular patch manufactured with the so called ADAPT® technology. The ADAPT technology uses bovine spongiform encephalopathy-free pericardium which is processed in several ways to make it biocompatible with human tissue. CardioCel should provide an off the shelf material solution for tri-leaflet repair surgery due to its functional attributes, low propensity for post implant calcification, and overall biocompatibility. As a result adverse events and complications associated with the autologous pericardium repair surgery are mitigated. In this study patients suffering from moderate-to-severe aortic stenosis and/or aortic insufficiency will be included. In this study 80 patients will be enrolled in up to 7 centers in Europe and the US. The expected study duration is 36 months; 12 months of recruitment and 24 months follow-up. CardioCel is US FDA cleared for the repair of cardiac and vascular defects, including intra-cardiac defects; septal defects, valve and annulus repair, great vessel reconstruction, peripheral vascular reconstruction, suture line buttressing and pericardial closure.

Conditions

• Aortic Stenosis
• Aortic Insufficiency

Interventions

Type	Name	Description
DEVICE	CardioCel	Treatment with CardioCel implant

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-07-05
• Completion: 2018-11-19
• First posted: 2015-12-14
• Last updated: 2019-01-29

Locations

1 site across 1 country: Belgium