CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 756 enrolled
Drug / intervention
Mitroflow Aortic Heart Valvedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00630916
NCT00630916N/ACompleted
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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

Sorin Group USA, Inc.·interventional·Posted Mar 7, 2008·Updated Sep 22, 2011

In Brief

A clinical study evaluating Mitroflow Aortic Heart Valve for Heart Valve Diseases. Completed, enrolled 756 participants across 26 sites in 2 countries.

Detailed Summary

This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Valve Diseases
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2008
Enrollment StartNov 1, 2003
Primary CompletionDec 1, 2005
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.3 years ago

Interventions

Mitroflow Aortic Heart Valvedevice

Replacement of the native aortic valve or a previously implanted prosthetic aortic valve