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TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

RecruitingNAAges 50 Years - anyAllDeutsches Herzzentrum Muenchen
NCT03600662 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • TriRec
  • Aortic valve replacement
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Where

1 site
Department of Cardiovascular Surgery, German Heart Center Munich
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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