Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Conditions
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Heart Valve Diseases

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized, multicenter trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Freedom SOLO stentless valve<br>Prospective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication. | Device: Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis<br>* The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complication and survival rates for the Freedom SOLO stentless valve. | 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. | up to 1 year | 
| The complication and survival rates for the Freedom SOLO stentless valve. | 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. | up to 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients | Decrease of transvalvular peak and mean pressure gradients from preoperative to follow up | up to 5 year | 
| Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography | Increase of effective orifice area (EOA) from preoperative to follow up | up to 5 year | 
| Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2). | Increase of effective orifice area index from preoperative to follow up. | up to 5 year | 
| Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition. | Improvement of Cardiac Output | up to 5 year | 
| Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition. | Improvement of Cardiac Index | up to 5 year | 
| Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition. | Evaluation of regurgitation, location and severity | up to 5 year | 
| Preoperative and postoperative NYHA functional classifications | NYHA functional classification data is presented as the number and percentage of patients in each functional class. | Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart diseases., Aortic valve diseases., Aortic valve insufficiency., Aortic valve stenosis.