TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
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- How often do I need to come in, and for how long each time?
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Deutsches Herzzentrum Muenchen
- Trial code
- NCT03600662
- Record updated
- 26 July 2018
- Original description
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.Read full original descriptionShow less
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: Age >= 50 years; Documented symptomatic moderate or greater aortic stenosis or severe insufficiency; Aortic annulus > 19 mm; Written informed consent of the patient.
Exclusion: Concomitant intervention of the aortic root; Concomitant intervention of the aortic arch; Concomitant valve surgery; Emergency surgery for any reason; Dual antiplatelet therapy; Previous cardiac surgery (excluding percutaneous procedures); Neurological events (i.e. stroke, TIA) within 6 months preoperatively; Coagulation disorders (including thrombocytopenia < 100.000/ml); Active endocarditis or other active systemic infections; Porcelain aorta; Participating in another trial that may influence the outcome of this trial; Pregnancy.