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Sponsored by: |
CarboMedics Inc. |
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Information provided by: | CarboMedics Inc. |
ClinicalTrials.gov Identifier: | NCT00630916 |
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.
Condition | Intervention |
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Heart Valve Diseases |
Device: Mitroflow Aortic Heart Valve |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve |
Enrollment: | 756 |
Study Start Date: | November 2003 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: No Intervention |
Device: Mitroflow Aortic Heart Valve
Replacement of the native aortic valve or a previously implanted prosthetic aortic valve
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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 bioprosthetic valves are known to have hemodynamic performance superior to porcine valves, and the excellent hemodynamic performance of pericardial valves is particularly relevant in patients with a small aortic root. However, long-term durability continues to be the main concern with use of pericardial valves. Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation techniques and design failure rather than the pericardial tissue.The unique desing of the Mitroflow Aortic Heart Valve may provide superior hemodynamic performance over other tissue valves.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Mary Onxley | CarboMedics Inc. |
Responsible Party: | CarboMedics ( Mary Onxley ) |
Study ID Numbers: | SYNPCR-01 |
Study First Received: | February 28, 2008 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00630916 |
Health Authority: | United States: Food and Drug Administration |
Aortic valve insufficiency Aortic valve Aortic disease Aortic incompetence |
Heart Diseases Aortic Diseases Aortic Valve Insufficiency Heart Valve Diseases |
Cardiovascular Diseases |