CardioCel Tri-leaflet Repair Study

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.

Inclusion criteria

• The subject's annular measurements are ≥ 19 mm to < 27mm as confirmed on pre-op echo and inter commissure distance equal to or bigger than 19mm as confirmed intraoperatively.
• The subject is suitable for a tri-leaflet repair.
• The subject has documented moderate-to-severe AS and/or AI.
• The subject is willing and able to comply with specified follow-up evaluations, including trans oesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve. The subject has reviewed and signed the written informed consent form.
• The subject upon final intraoperative assessment has intracardiac anatomy suitable for tri-leaflet repair using CardioCel.

Exclusion criteria

• Greater than 85 years of age at the time of consent.
• The subject's annular measurements < 19 mm or > 27mm.
• All patients will be excluded who require emergent surgery (within 24 hours of a presentation to an emergency department) for any reason.
• The subject will be excluded with pre-existing valve prosthesis in the aortic position.
• Patients requiring repair of other cardiac valves will be excluded.
• The subject has active endocarditis.
• Heavily calcified aortic roots or "porcelain aortas" (as evidenced on cardiac echo).
• Leukopenia with a WBC of less than 3000 cells per microliter.
• Acute anaemia with a haemoglobin less than 8 g/dL.
• Platelet count less than 150.000 platelets/microliter.
• History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions.
• Active infection requiring antibiotic therapy (if temporary illness, subjects may enrol 2-4 weeks after discontinuation of antibiotics).
• Subjects in whom trans oesophageal echocardiography (TEE) is contraindicated.
• Low Ejection Fraction (EF) < 35%.
• Life expectancy < 1 year, or severe comorbidities, such as cancer, dialysis, or severe COPD at the investigator's discretion
• The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or is unable to give informed consent.
• The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test for all child bearing potential females prior to enrolment).
• Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
• Myocardial Infarction (MI) within one month of trial inclusion
• Upon intraoperative assessment of the intracardiac anatomy the patient is not suitable for tri-leaflet repair using CardioCel.