Freedom SOLO Stentless Heart Valve Study

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.

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

Official Title
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Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America

Conditions
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Aortic Stenosis, Aortic Insufficiency

Intervention / Treatment
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* Device: Freedom SOLO Stentless Heart Valve


Participation Criteria
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Eligibility Criteria
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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.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freedom SOLO stentless valve implant<br>Appropriate subjects will receive the Freedom SOLO stentless valve implant as a replacement for a diseased or damaged native or prosthetic aortic valve. | Device: Freedom SOLO Stentless Heart Valve<br>* Freedom SOLO Stentless Heart Valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be determined by incidence rate of adverse events | The complication and survival rates for the SOLO valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported in the literature for other stentless bioprostheses and stented pericardial valves. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be determined by hemodynamics | The hemodynamic performance of the SOLO valve will be compared to that reported in the literature for other stentless bioprostheses and stented pericardial valves. | 1 year | 
| Effectiveness will be determined by NYHA Classification comparisons | Clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic, Valve replacement