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

Aortic Valve Disease Clinical Trial

Official title:

A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00619151
• Other study ID #: RVSS-1H
• Status: Terminated
• Phase: N/A
• First received: January 10, 2008
• Last updated: November 7, 2011
• Start date: December 2007
• Est. completion date: May 2008

Study information

• Verified date: September 2011
• Source: Sorin Group USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Device:
• Top Hat
Implant of CarboMedics Top Hat mechanical valve.
• Regent
Implant of the St. Jude Medical Regent mechanical valve

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Sorin Group USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Orifice Area (EOA)	Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.	6 month evaluation	No
Primary	Aortic Mean Gradient	Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.	6 months	No