Aortic Stenosis Clinical Trial
Official title:
CardioCel Tri-leaflet Repair Study; a Prospective, Non-randomised, Single Arm, Multi-centre Clinical Investigation
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.
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.
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