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

NCT00477555 | Completed

• 1 other identifier: BRC-CS-14075
• Study Type: observational
• Target: 43
• Locations: 5 countries
• Sites: 11

Brief 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

Keywords

aortic valve; concomitant procedures; porcine bioprosthesis; stented valve

Interventions

Aortic implantation of Mosaic Ultra porcine bioprosthesis DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are eligible for an aortic valve replacement can be enrolled in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (11)

Medinische Universitat Innsbruck

Innsbruck, A-6020, Austria

Location

ZNA Middelheim

Antwerp, Antwerp, 2020, Belgium

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

Hopital St Luc

Bouge, 5004, Belgium

Location

Klinik fur Thorax- Herz und Gefasschirurgie

Dortmund, 44139, Germany

Location

Klinikum der Johann-Wolfgang-Goethe Universitat

Frankfurt Am Mein, 60590, Germany

Location

Albertinen Krankenhaus

Hamburg, 22457, Germany

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadasit Medical Research Services

Jerusalem, 91120, Israel

Location

U.O. Cardiochirurgia del p.p. Civico

Palermo, 90127, Italy

Location

Study Officials

• Jaak Minten, PhD

  Clinical Director Cardiac Surgery Medtronic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 23, 2007
• Study Start: April 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

AU (1); DE (3); BE (3); IL (3); IT (1)