Heart Valve Diseases
Conditions
Keywords
Heart diseases., Aortic valve diseases., Aortic valve insufficiency., Aortic valve stenosis.
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 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.
Interventions
DEVICESurgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.
Sponsors
Corcym S.r.l
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized, multicenter trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The complication and survival rates for the Freedom SOLO stentless valve. | up to 1 year | Safety of the Freedom SOLO was evaluated based on the following adverse events related to cardiac valve replacement: valve thrombosis, thromboembolism, bleeding, anticoagulant-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, nonstructural dysfunction, structural valve deterioration, reoperation, explant, and death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography | up to 5 year | Increase of effective orifice area (EOA) from preoperative to follow up |
| Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2). | up to 5 year | Increase of effective orifice area index from preoperative to follow up. |
| Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition. | up to 5 year | Improvement of Cardiac Output |
| Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients | up to 5 year | Decrease of transvalvular peak and mean pressure gradients from preoperative to follow up |
| Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition. | up to 5 year | Evaluation of regurgitation, location and severity |
| Preoperative and postoperative NYHA functional classifications | Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter | NYHA functional classification data is presented as the number and percentage of patients in each functional class. |
| Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition. | up to 5 year | Improvement of Cardiac Index |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Switzerland
Outcome results
None listed