Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position
NCT00477555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43
Last updated 2015-10-29
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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