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Sponsored by: |
CarboMedics Inc. |
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Information provided by: | CarboMedics Inc. |
ClinicalTrials.gov Identifier: | NCT00705913 |
The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
Condition | Intervention |
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Aortic Valve Disease |
Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics) Device: Carpentier-Edwards Magna Tissue Valve |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Randomized Study to Compare Sizing, Implant Techniques and Hemodynamic Performance Between the Mitroflow and the Carpentier-Edwards Magna Pericardial Tissue Valves in the Aortic Position |
Estimated Enrollment: | 384 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
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Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve
|
2: Active Comparator |
Device: Carpentier-Edwards Magna Tissue Valve
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve
|
Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara P. Mathews, BSN, MSN | 512-435-3602 | barbara.mathews@sorin.com |
Contact: John Villarreal, BA | 512-435-3207 | john.villarreal@sorin.com |
United States, California | |
Sharp Memorial Hospital | Not yet recruiting |
San Diego, California, United States, 92123 | |
Contact: Debbie King 858-300-4747 debbiecking@hotmail.com | |
Principal Investigator: Sam Baradarian, MD | |
United States, Kansas | |
St. Luke's Medical Center | Recruiting |
Kansas City, Kansas, United States | |
Contact: Keith Allen, MD | |
Principal Investigator: Keith Allen, MD | |
United States, Maryland | |
Peninsula Regional Medical Center | Recruiting |
Salisbury, Maryland, United States, 21801 | |
Contact: Lori Short 410-543-7530 shortnurse@netzero.com | |
Principal Investigator: Michael Todd, MD | |
United States, Missouri | |
St. John's Medical Research Inst. | Recruiting |
Springfield, Missouri, United States, 65807 | |
Contact: Rebecca Baker 417-820-4184 Rebecca.baker@Mercy.net | |
Principal Investigator: Sirish Parvathaneni, MD | |
United States, North Carolina | |
Duke University Hospital | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: Terry Ainsworth 919-668-2382 ainsw001@mc.duke.edu | |
Principal Investigator: Chad Hughes, MD | |
United States, Ohio | |
The Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Danielle Jones 614-336-8506 Danielle.Jones@osumc.edu | |
Principal Investigator: Michael Firstenberg, MD | |
United States, Oregon | |
Providence St. Vincents Medical Center | Recruiting |
Portland, Oregon, United States, 97225 | |
Contact: Eric Johnson 503-216-2075 eric.johnson@providence.org | |
Principal Investigator: Jeffrey Swanson, MD | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Kristen Burtch 215-429-3432 Kristen.Burtch@uphs.upenn.edu | |
Principal Investigator: Joseph Bavaria, MD | |
United States, Texas | |
The Heart Hospital Baylor Plano | Recruiting |
Plano, Texas, United States, 75093 | |
Contact: Shannon Hoffman 469-814-3466 shannhof@baylorhealth.edu | |
Principal Investigator: William Ryan, MD | |
Canada, Manitoba | |
St.Boniface General Hospital | Recruiting |
Winnipeg, Manitoba, Canada, R2H 2A6 | |
Contact: Rachel Gerstein 204-237-2793 rgerstein@sbgh.mb.ca | |
Principal Investigator: John Lee, MD |
Responsible Party: | CarboMedics Inc. ( Barbara Mathews/Senior Director Clinical Research ) |
Study ID Numbers: | MRVSS-02 |
Study First Received: | June 18, 2008 |
Last Updated: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00705913 History of Changes |
Health Authority: | United States: Institutional Review Board |
aortic valve heart valve valve replacement valve disease |