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Clinical Trials in Germany / NCT03600662
Recruiting Not applicable

TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

NCT03600662 · tracked via the Priya Life Science Germany tracker
Sponsor
Deutsches Herzzentrum Muenchen
Phase
Not applicable
Started
2018-01-18
Last updated
2018-07-26

Condition(s) studied

Alternative Surgical Treatment for Aortic Valve Disease

Investigational drug(s) / intervention(s)

TriRecAortic valve replacement

TriRec: Trileaflet Reconstruction of the Aortic Valve

Aortic valve replacement: Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Study summary

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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Effective orifice area — 10th postoperative day +/- 4 days
    Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography

Trial sites (1)

FacilityCityRegionStatus
Department of Cardiovascular Surgery, German Heart Center Munich Munich Bavaria Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03600662 on ClinicalTrials.gov ↗ ← All trials in Germany