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

This study has been completed.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00477555
First received: May 21, 2007
Last updated: July 26, 2010
Last verified: July 2010
  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

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Estimated Enrollment: 150
Study Start Date: April 2006
Study Completion Date: January 2010
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

Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Minten Jaak, Clinical Research Director, Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00477555     History of Changes
Other Study ID Numbers: BRC-CS-14075
Study First Received: May 21, 2007
Last Updated: July 26, 2010
Health Authority: Belgium: Institutional Review Board
Germany: Ethics Commission
Italy: Ethics Committee
Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on July 26, 2014