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

Stopped early · Not applicable

Conditions studied: Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT00619151

Run by

Sorin Group USA, Inc.

People needed

2

Starts

2007-12-01

Expected to finish

2008-05-01

Last updated by the study team

2011-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients < 18 years of age
• Emergency surgery
• Pre-existing valve prosthesis
• Aortic root replacement
• Active endocarditis

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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