CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics - Full Text View

Sponsored by:	CarboMedics Inc.
Information provided by:	CarboMedics Inc.
ClinicalTrials.gov Identifier:	NCT00619151

Purpose

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.

Condition	Intervention
Aortic Valve Disease	Device: Top Hat Aortic Valve (CarboMedics) Device: St. Jude Medical Regent

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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.

Further study details as provided by CarboMedics Inc.:

Primary Outcome Measures:

The ability to implant a larger internal orifice diameter relative to the native aortic annulus. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	December 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator CarboMedics Supra-annular Top Hat Valve	Device: Top Hat Aortic Valve (CarboMedics) Study to compare sizing, implant techniques, and hemodynamics of the CarboMedics Top Hat supra-annular valve as compared to the St. Jude Medical Regent valve.
2: Active Comparator St. Jude Medical Regent Valve	Device: St. Jude Medical Regent Study to compare sizing, implant techniques, and hemodynamics of the Top Hat supra-annular valve as compared to the St. Jude Medical Regent valve.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619151

Locations

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Tennessee
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660

Sponsors and Collaborators

CarboMedics Inc.

More Information

Responsible Party:	Sorin Group ( Barbara Mathews, RN, MSN / Senior Director Clinical Research CVH )
Study ID Numbers:	RVSS-1H
Study First Received:	January 10, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00619151
Health Authority:	United States: Institutional Review Board

Keywords provided by CarboMedics Inc.:

aortic valve
heart valve
valve replacement
Valve disease

ClinicalTrials.gov processed this record on January 16, 2009