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TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

RECRUITINGN/ASponsored by Deutsches Herzzentrum Muenchen
Actively Recruiting
PhaseN/A
SponsorDeutsches Herzzentrum Muenchen
Started2018-01-18
Est. completion2020-01
Eligibility
Age50 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT03600662

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

Age: 50 Years+Healthy volunteers accepted
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)

Conditions2

Alternative Surgical Treatment for Aortic Valve DiseaseHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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