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TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

NCT03600662 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-07-26

No results posted yet for this 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.

Conditions

  • Alternative Surgical Treatment for Aortic Valve Disease

Interventions

OTHER

TriRec

Trileaflet Reconstruction of the Aortic Valve

OTHER

Aortic valve replacement

Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Sponsors & Collaborators

  • Department of Cardiovascular Surgery, German Heart Center Munich

    collaborator UNKNOWN

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Markus Krane, MD, PhD · Department of Cardiovascular Surgery, German Heart Center Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2020-01-31
Completion
2030-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600662 on ClinicalTrials.gov