Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position

NCT00477555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2015-10-29

No results posted yet for this study

Summary

The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcification and improves hemodynamic performance and a potential for increased durability. This study will document the hemodynamic performance, as assessed by echocardiographic recordings, at six months post implantation.

Conditions

  • Aortic Valve Replacement
  • Coronary Artery Bypass Grafting

Interventions

DEVICE

Aortic implantation of Mosaic Ultra porcine bioprosthesis

All patients get implanted with a Mosaic Ultra tissue valve to evaluate hemodynamic performance at 6 months post implant.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Jaak Minten, PhD · Clinical Director Cardiac Surgery Medtronic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Austria
  • Belgium
  • Germany
  • Israel
  • Italy

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 NCT00477555 on ClinicalTrials.gov