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

NCT00619151 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2011-11-16

Study results available
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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.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

Top Hat

Implant of CarboMedics Top Hat mechanical valve.

DEVICE

Regent

Implant of the St. Jude Medical Regent mechanical valve

Sponsors & Collaborators

  • Sorin Group USA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00619151 on ClinicalTrials.gov