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

NCT ID: NCT00619151

Last Updated: 2011-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Aortic Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

CarboMedics Supra-annular Top Hat Valve

Group Type ACTIVE_COMPARATOR

Top Hat

Intervention Type DEVICE

Implant of CarboMedics Top Hat mechanical valve.

2

St. Jude Medical Regent Valve

Group Type ACTIVE_COMPARATOR

Regent

Intervention Type DEVICE

Implant of the St. Jude Medical Regent mechanical valve

Interventions

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Top Hat

Implant of CarboMedics Top Hat mechanical valve.

Intervention Type DEVICE

Regent

Implant of the St. Jude Medical Regent mechanical valve

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorin Group USA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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RVSS-1H

Identifier Type: -

Identifier Source: org_study_id