TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorDeutsches Herzzentrum Muenchen
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.
Eligibility criteria
Qualifiers
Age >= 50 years
Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
Aortic annulus > 19 mm
Written informed consent of the patient.
Disqualifiers
Concomitant intervention of the aortic root
Concomitant intervention of the aortic arch
Concomitant valve surgery
Emergency surgery for any reason
Trial design
Treatments tested in this trial
- TriRec
- Aortic valve replacement
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Deutsches Herzzentrum Muenchen
Lead sponsor
Department of Cardiovascular Surgery, German Heart Center Munich
Collaborator
Source ClinicalTrials.gov