Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Corcym

Status

Completed

Conditions

Heart Valve Diseases

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00876525

V10604

Details and patient eligibility

About

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.

Full 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.

Enrollment

702 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.