Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Aortic Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Mitroflow Aortic Pericardial Heart Valve (CarboMedics)

Group Type ACTIVE_COMPARATOR

Mitroflow Aortic Pericardial Heart Valve (CarboMedics)

Intervention Type DEVICE

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

2

Group Type ACTIVE_COMPARATOR

Carpentier-Edwards Magna Tissue Valve

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No