Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
This study has been terminated.
Sponsor:
Sorin Group USA, Inc.
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT00705913
First received: June 18, 2008
Last updated: January 6, 2012
Last verified: November 2011
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Purpose
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 |
|---|---|
|
Aortic Valve Disease |
Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics) Device: Carpentier-Edwards Magna Tissue Valve |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Further study details as provided by Sorin Group USA, Inc.:
Primary Outcome Measures:
- Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 368 |
| Study Start Date: | June 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
|
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
|
| Active Comparator: 2 |
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
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.
Exclusion Criteria:
- Less than 18 years of age
- Emergency Surgery
- Pre-existing valve prothesis in the aortic position
- Aortic root replacements or enlargements
- Active endocarditis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705913
Locations
| United States, California | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Pepin Heart Hospital | |
| Tampa, Florida, United States, 33613 | |
| United States, Kansas | |
| St. Luke's Medical Center | |
| Kansas City, Kansas, United States, 64111 | |
| United States, Maryland | |
| Peninsula Regional Medical Center | |
| Salisbury, Maryland, United States, 21801 | |
| United States, Missouri | |
| St. John's Medical Research Inst. | |
| Springfield, Missouri, United States, 65807 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Duke University Hospital | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| The Heart Hospital Baylor Plano | |
| Plano, Texas, United States, 75093 | |
| Canada, Manitoba | |
| St.Boniface General Hospital | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Quebec | |
| Hopital Laval | |
| Sainte-Foy, Quebec, Canada, G1V 6G5 | |
Sponsors and Collaborators
Sorin Group USA, Inc.
More Information
No publications provided
| Responsible Party: | Sorin Group USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00705913 History of Changes |
| Other Study ID Numbers: | MRVSS-02 |
| Study First Received: | June 18, 2008 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sorin Group USA, Inc.:
|
aortic valve heart valve valve replacement valve disease |
ClinicalTrials.gov processed this record on May 21, 2013