Freedom SOLO Stentless Heart Valve Study

The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the SOLO Freedom heart valve implanted in patients requiring aortic valve replacement.

Inclusion criteria

• The subject is male or female 18 years old or older.
• The subject or subject's legal representative is willing to sign the informed consent.
• The subject which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
• Any subject 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 subject 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).
• Subject will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion criteria

• The subject has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
• The subject requires a double or multiple valve replacement (a valve repair is not considered an exclusion criterion).
• The subject has a previously implanted SOLO valve, within the clinical study, that requires replacement.
• The subject has active endocarditis or myocarditis.
• The subject is or will be participating in a concomitant research study of an investigational product.
• The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
• The subject 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 subject.
• The subject is pregnant, planning to become pregnant or lactating.
• The subject has a congenital bicuspid aortic valve.
• The subject is known to be noncompliant or is unlikely to complete the study.
• The subject is undergoing renal dialysis for chronic renal failure or has been diagnosed with hyperparathyroidism.
• The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
• The subject has extensive calcification of the aortic root where removal of the calcified tissue cannot be achieved.
• The subject has a significantly dilated aortic root that is not surgically corrected.
• The subject requires replacement of the aortic root / full root procedure.