Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
- Conditions
- Aortic Valve Disease
- Interventions
- Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)Device: Carpentier-Edwards Magna Tissue Valve
- Registration Number
- NCT00705913
- Lead Sponsor
- Sorin Group USA, Inc.
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 368
- 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.
- Less than 18 years of age
- Emergency Surgery
- Pre-existing valve prothesis in the aortic position
- Aortic root replacements or enlargements
- Active endocarditis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Mitroflow Aortic Pericardial Heart Valve (CarboMedics) Mitroflow Aortic Pericardial Heart Valve (CarboMedics) 2 Carpentier-Edwards Magna Tissue Valve -
- Primary Outcome Measures
Name Time Method Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus 6 months
- Secondary Outcome Measures
Name Time Method Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area. 6 months
Trial Locations
- Locations (12)
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Pepin Heart Hospital
🇺🇸Tampa, Florida, United States
Hopital Laval
🇨🇦Sainte-Foy, Quebec, Canada
St.Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
St. Luke's Medical Center
🇺🇸Kansas City, Kansas, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
St. John's Medical Research Inst.
🇺🇸Springfield, Missouri, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States