This trial is active, not recruiting.

Condition heart valve diseases
Treatment freedom solo
Sponsor LivaNova
Start date March 2009
End date December 2013
Trial size 700 participants
Trial identifier NCT00876525, V10604


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
freedom solo
The Freedom SOLO heart valve prosthesis is a stentless bioprosthesis manufactured with bovine pericardium.

Primary Outcomes

The complication and survival rates for the Freedom SOLO stentless valve.
time frame: Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion.

Secondary Outcomes

Hemodynamic performance of the Freedom SOLO stentless valve. Clinically significant improvement in overall patient condition.
time frame: Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Principal investigator Markus Thalmann, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by LivaNova.