Actively Recruiting
TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Led by Deutsches Herzzentrum Muenchen · Updated on 2018-07-26
128
Participants Needed
1
Research Sites
623 weeks
Total Duration
On this page
Sponsors
D
Deutsches Herzzentrum Muenchen
Lead Sponsor
D
Department of Cardiovascular Surgery, German Heart Center Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3e= 50 years
- Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
- Aortic annulus > 19 mm
- Written informed consent of the patient.
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Cardiovascular Surgery, German Heart Center Munich
Munich, Bavaria, Germany, 80336
Actively Recruiting
Research Team
M
Markus Krane, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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