Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center ) Identifier:
First received: May 21, 2007
Last updated: October 28, 2015
Last verified: October 2015
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:

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


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00477555

Medinische Universitat Innsbruck
Innsbruck, Austria, A-6020
ZNA Middelheim
Antwerpen, Antwerp, Belgium, 2020
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
Hopital St Luc
Bouge, Belgium, 5004
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
Soroka University Medical Center
Beer Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 31096
Hadasit Medical Research Services
Jerusalem, Israel, 91120
U.O. Cardiochirurgia del p.p. Civico
Palermo, Italy, 90127
Sponsors and Collaborators
Medtronic Bakken Research Center
Study Director: Jaak Minten, PhD Clinical Director Cardiac Surgery Medtronic
  More Information

Responsible Party: Medtronic Bakken Research Center Identifier: NCT00477555     History of Changes
Other Study ID Numbers: BRC-CS-14075
Study First Received: May 21, 2007
Last Updated: October 28, 2015

Keywords provided by Medtronic Cardiovascular:
aortic valve
concomitant procedures
porcine bioprosthesis
stented valve processed this record on April 26, 2017