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Clinical Investigation of the Freedom SOLO Stentless Heart Valve

NCT00876525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Heart Valve Diseases

Interventions

DEVICE

Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis

The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.

Sponsors & Collaborators

  • Corcym S.r.l

    lead INDUSTRY

Principal Investigators

  • Markus Thalmann, MD · KH Hietzing Wien

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-12-31
Completion
2017-12-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Switzerland

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 NCT00876525 on ClinicalTrials.gov