Status:
COMPLETED
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
Lead Sponsor:
Sorin Group USA, Inc.
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Detailed Description
Bioprosthetic heart valves offer several advantages over mechanical valves, the most important being freedom from the need for anticoagulation and a low rate of thromboembolic events. Pericardial biop...
Eligibility Criteria
Inclusion
- The subject is male or female 18 years old or older
- The subject or subject's legal representative is willing to sign the informed consent
- A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center
- The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
Exclusion
- The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position
- The patient requires a double or triple valve replacement
- The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted
- The patient has active endocarditis
- The subject is or will be participating in a concomitant research study of an investigational product
- The subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
- The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT00630916
Start Date
November 1 2003
End Date
December 1 2007
Last Update
September 22 2011
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Good Samaritan
Phoenix, Arizona, United States, 85006
2
The University of Arizona
Tucson, Arizona, United States, 85724
3
Sharp Memorial Hospital
San Diego, California, United States, 92123
4
Methodist Hospital
Indianapolis, Indiana, United States, 46206