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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00705913

Enrollment

368

Registered

2008-06-27

Start date

2008-06-30

Completion date

2011-09-30

Last updated

2012-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

Keywords

aortic valve, heart valve, valve replacement, valve disease

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

Interventions

DEVICEMitroflow 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

DEVICECarpentier-Edwards Magna Tissue Valve

Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus	6 months

Secondary

Measure	Time frame
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026