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TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

Recruiting
50 years and older
All
Phase N/A

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Overview

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.

Eligibility

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)

Study details
    Alternative Surgical Treatment for Aortic Valve Disease

NCT03600662

Deutsches Herzzentrum Muenchen

27 January 2024

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