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

Not Applicable

Terminated

• Conditions: Aortic Valve Disease
• Interventions: Device: Top Hat; Device: Regent

• Registration Number: NCT00619151
• Lead Sponsor: Sorin Group USA, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-20
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2011-06-07
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-20
• Results First Posted: 2011-11-03
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Top Hat	CarboMedics Supra-annular Top Hat Valve
2	Regent	St. Jude Medical Regent Valve

Primary Outcome Measures

Name	Time	Method
Effective Orifice Area (EOA)	6 month evaluation	Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
Aortic Mean Gradient	6 months	Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.

Trial Locations

Locations (2)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Wellmont Holston Valley Medical Center; 🇺🇸 Kingsport, Tennessee, United States