Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Sorin

Status: Terminated

Conditions: Aortic Valve Disease

Treatments: Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics); Device: Carpentier-Edwards Magna Tissue Valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705913

MRVSS-02

Details and patient eligibility

About

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.

Full 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

Enrollment: 368 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 2 patient groups

1

Active Comparator group

Description:

Mitroflow Aortic Pericardial Heart Valve (CarboMedics)

Treatment:

Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)

2

Active Comparator group

Treatment:

Device: Carpentier-Edwards Magna Tissue Valve