Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
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
1 other identifier
interventional
368
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJanuary 9, 2012
November 1, 2011
3.3 years
June 18, 2008
January 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus
6 months
Secondary Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATORMitroflow Aortic Pericardial Heart Valve (CarboMedics)
2
ACTIVE COMPARATORInterventions
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Less than 18 years of age
- Emergency Surgery
- Pre-existing valve prothesis in the aortic position
- Aortic root replacements or enlargements
- Active endocarditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Sharp Memorial Hospital
San Diego, California, 92123, United States
Pepin Heart Hospital
Tampa, Florida, 33613, United States
St. Luke's Medical Center
Kansas City, Kansas, 64111, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
St. John's Medical Research Inst.
Springfield, Missouri, 65807, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Hospital
Durham, North Carolina, 27705, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
St.Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Hopital Laval
Sainte-Foy, Quebec, G1V 6G5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 27, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
January 9, 2012
Record last verified: 2011-11