Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
186 participants
INTERVENTIONAL
2015-03-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mitroflow DL
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Mitroflow DL
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Interventions
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Mitroflow DL
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient or patient's legal representative is willing to sign the informed consent.
3. Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement
4. Any patient amenable to aortic valve replacement with a biological prosthesis should be enrolled in the study, even in conjuction with valve repair, coronary artery bypass grafting and other procedures
5. Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable).
Exclusion Criteria
2. The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position.
3. Patient requires a double or triple valve replacement (repair is not considered an exclusion).
4. Patient has active endocarditis or myocarditis.
5. Patient is pregnant or lactating.
6. Patient is participating in a concomitant research study of an investigational product.
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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John Kern, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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UCLA Medical Center
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
River City Clinical Research
Jacksonville, Florida, United States
UF Health - Jacksonville
Jacksonville, Florida, United States
Watson Clinic Center for Research
Lakeland, Florida, United States
Suburban Hospital - John Hopkins Medicine
Bethesda, Maryland, United States
Bay Regional Medical Center
Bay City, Michigan, United States
St. John Hospital & Medical Center
Detroit, Michigan, United States
Catholic Medical Center
Manchester, New Hampshire, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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TMT001
Identifier Type: -
Identifier Source: org_study_id
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