RecruitingNot ApplicableNCT03600662

TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

TriRec - Trileaflet Reconstruction of the Aortic Valve

Sponsor

Deutsches Herzzentrum Muenchen

Enrollment

128 participants

Start Date

Jan 18, 2018

Study Type

INTERVENTIONAL

Conditions

Alternative Surgical Treatment for Aortic Valve Disease

Summary

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

Min Age: 50 Years

Inclusion Criteria4

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

Exclusion Criteria12

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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Interventions

OTHERTriRec

Trileaflet Reconstruction of the Aortic Valve

OTHERAortic valve replacement

Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Locations(1)

Department of Cardiovascular Surgery, German Heart Center Munich

Munich, Bavaria, Germany

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NCT03600662