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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477555
First Posted: May 23, 2007
Last Update Posted: October 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
  Purpose
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.

Condition Intervention
Aortic Valve Replacement Coronary Artery Bypass Grafting Device: Aortic implantation of Mosaic Ultra porcine bioprosthesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mosaic Ultra Porcine Bioprosthesis - Hemodynamic Study

Further study details as provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):

Enrollment: 43
Study Start Date: April 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are eligible for an aortic valve replacement can be enrolled in the study.
Criteria

Inclusion Criteria:

  • Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of Atrial Fibrillation.
  • Patients who are able to provide informed consent.

Exclusion Criteria:

  • Concomitant procedures other than coronary artery bypass grafting or surgical treatment of Atrial Fibrillation.
  • Patients indicated for receiving a mechanical prosthesis.
  • Patients who will have a replacement of an existing valve prosthesis.
  • Patients refusing or not able to provide informed consent.
  • Patients requiring emergency surgery.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477555


Locations
Austria
Medinische Universitat Innsbruck
Innsbruck, Austria, A-6020
Belgium
ZNA Middelheim
Antwerpen, Antwerp, Belgium, 2020
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
Hopital St Luc
Bouge, Belgium, 5004
Germany
Klinik fur Thorax- Herz und Gefasschirurgie
Dortmund, Germany, 44139
Klinikum der Johann-Wolfgang-Goethe Universitat
Frankfurt am Mein, Germany, 60590
Albertinen Krankenhaus
Hamburg, Germany, 22457
Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 31096
Hadasit Medical Research Services
Jerusalem, Israel, 91120
Italy
U.O. Cardiochirurgia del p.p. Civico
Palermo, Italy, 90127
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Study Director: Jaak Minten, PhD Clinical Director Cardiac Surgery Medtronic
  More Information

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00477555     History of Changes
Other Study ID Numbers: BRC-CS-14075
First Submitted: May 21, 2007
First Posted: May 23, 2007
Last Update Posted: October 29, 2015
Last Verified: October 2015

Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
aortic valve
concomitant procedures
porcine bioprosthesis
stented valve