CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

N/ATerminatedNCT00619151

Sorin Group USA, Inc.2 enrolled

Overview

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Aortic Valve Disease

Interventions

Top HatDEVICE

Implant of CarboMedics Top Hat mechanical valve.

RegentDEVICE

Implant of the St. Jude Medical Regent mechanical valve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center. Exclusion Criteria: * Patients \< 18 years of age * Emergency surgery * Pre-existing valve prosthesis * Aortic root replacement * Active endocarditis

Locations (2)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Outcomes

Primary Outcomes

Effective Orifice Area (EOA)

Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.

Time frame: 6 month evaluation

Aortic Mean Gradient

Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.

Time frame: 6 months

Data from ClinicalTrials.gov

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