NCT00876525

Clinical Investigation of the Freedom SOLO Stentless Heart Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: Corcym S.r.l · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-12-01
• Completion: 2017-12-01
• First posted: 2009-04-06
• Last updated: 2024-03-06

Locations

19 sites across 8 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Switzerland