Clinical Investigation of the Freedom SOLO stentless Heart valve

Completed

• Conditions: aortic valve stenosis/insufficiency; leakage of aortic valve; 10046973

• Registration Number: NL-OMON56813
• Lead Sponsor: Sorin Biomedica CRM SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patient with pre operative evaluation indicated the need for native or prosthetic aortic valve replacement.
Any patient amenable to aortic valve replacement with biologcal prothesis, even in conjuction with valve repair, CABG and other procedures.
Patient will be available to investigator for post-operative follow up beyond one year.

Exclusion Criteria

Patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
Patient requires a double or triple valve replacement.
Patient had previously implanted SOLO valve within th clinical study that requires replacement.
Patient has major or progressive non-cardiac disease that, in the investigator's experience results in life expectancy of less than 1 year or the implant of the device produces an unacceptable increased risk to the patient.
Patients with congenital bicuspid aortic valve.
Patient has active endocarditis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified