Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Sorin Group USA, Inc.368 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

368

Conditions

Aortic Valve Disease

Interventions

Mitroflow Aortic Pericardial Heart Valve (CarboMedics)DEVICE

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

Carpentier-Edwards Magna Tissue ValveDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Sharp Memorial Hospital

San Diego, California, United States

Pepin Heart Hospital

Tampa, Florida, United States

St. Luke's Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.

Time frame: 6 months

Data from ClinicalTrials.gov

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