TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

TriRec - Trileaflet Reconstruction of the Aortic Valve

Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St. Jude Trifecta GT) as gold- standard.

Inclusion Criteria:

• Age >= 50 years
• Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
• Aortic annulus > 19 mm
• Written informed consent of the patient.

Exclusion Criteria:

• Concomitant intervention of the aortic root
• Concomitant intervention of the aortic arch
• Concomitant valve surgery
• Emergency surgery for any reason
• Neurological events (i.e. stroke, TIA) within 6 months preoperatively
• Coagulation disorders (including thrombocytopenia < 100.000/ml)
• Porcelain aorta
• Active endocarditis or other active systemic infections
• Participating in another trial that may influence the outcome of this trial
• Pregnancy
• Dual antiplatelet therapy
• Previous cardiac surgery (excluding percutaneous procedures)