Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Status Completed

Clinical Trial Summary

This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Clinical Trial Description

Freedom SOLO study is a prospective, non-randomized, multicenter trial on the Freedom SOLOvalve implanted in patients requiring aortic valve replacement. The study was conducted at 18 centers in Europe. The study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria (OPCs). Based on the guidelines established by the U.S. Food and Drug Administration (FDA), the minimum sample size for this study was 800 valve-years, which is the minimum amount of data needed to test against the OPC of 1.2 %/patient-year. ;

Study Design

Related Conditions & MeSH terms

Heart Valve Diseases

Clinical Trial Details

NCT number	NCT00876525
Study type	Interventional
Source	Corcym S.r.l
Contact
Status	Completed
Phase	N/A
Start date	March 2009
Completion date	December 2017

View Details

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