TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

German Heart Center Munich

Status: Enrolling

Conditions: Alternative Surgical Treatment for Aortic Valve Disease

Treatments: Other: Aortic valve replacement; Other: TriRec

Study type: Interventional

Funder types: Other

Identifiers

NCT03600662

389/17S

Details and patient eligibility

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

TriRec

Experimental group

Description:

Trileaflet Reconstruction of the Aortic Valve

Treatment:

Other: TriRec

Aortic valve replacement

Experimental group

Description:

Biological prosthesis, Device: St. Jude Medical Trifecta GT

Treatment:

Other: Aortic valve replacement