Status:
COMPLETED
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Lead Sponsor:
Corcym S.r.l
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Europ...
Eligibility Criteria
Inclusion
- The patient is male or female 18 years old or older.
- The patient is willing to sign the informed consent.
- The patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
- Any patient amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
- The patient is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
- Patient will be available to the investigator(s) for postoperative follow-up beyond one year.
Exclusion
- The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
- The patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion).
- The patient has a previously implanted SOLO valve, within the clinical study, that requires replacement.
- The patient has active endocarditis.
- The patient is or will be participating in a concomitant research study of an investigational product.
- The patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.
- The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
- The patient is pregnant or lactating.
- Patients with congenital bicuspid aortic valve.
- Patients are known to be noncompliant or are unlikely to complete the study.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT00876525
Start Date
March 1 2009
End Date
December 1 2017
Last Update
March 6 2024
Active Locations (19)
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1
Krankenhaus Hietzing
Vienna, Austria, 1030
2
Medical University Vienna
Vienna, Austria, 1090
3
St. Luc Hospital
Brussels, Belgium, 1200
4
University Hospital Gent
Ghent, Belgium, 9000