TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Recruiting
N/A
Interventional Study
Alternative Surgical Treatment for Aortic Valve Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 128 (estimated)
- Sponsor
- Deutsches Herzzentrum Muenchen · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 aort…
Contacts