TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

Launched by DEUTSCHES HERZZENTRUM MUENCHEN · Jul 16, 2018

Keywords

ClinConnect Summary

The TriRec clinical trial is studying a new method for repairing the aortic valve in patients with heart valve disease. This method uses a special technique called tri-leaflet reconstruction, which aims to fix the valve using the patient’s own heart tissue, rather than replacing it with a mechanical or biological prosthesis. Researchers want to see if this new approach works as well as the standard surgery, known as surgical aortic valve replacement (SAVR), which involves replacing the valve with an artificial one.

To participate in this trial, you need to be at least 50 years old and have moderate to severe issues with your aortic valve, such as a narrowing (stenosis) or leakage (insufficiency). You also need to be able to give written consent to take part in the study. If you have certain health conditions, like recent strokes, active infections, or previous heart surgeries, you may not be eligible. If you join the trial, you can expect to receive careful monitoring and follow-up care as researchers evaluate the safety and effectiveness of this new valve repair technique.

Gender

ALL

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 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)