Freedom SOLO Stentless Heart Valve Study

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:December 2010
End Date:June 2017

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

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

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

- 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

- 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.
We found this trial at
223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
Ridgewood, NJ
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
Atlanta, GA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Los Angeles, CA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
Philadelphia, PA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Cleveland, OH
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18101 Oakwood Blvd
Dearborn, Michigan 48124
Oakwood Hospital For more than 60 years, Oakwood Hospital - Dearborn (OH-D) has proudly served...
Dearborn, MI
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Indianapolis, Indiana 46290
Indianapolis, IN
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
Toledo, OH
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Wynnewood, Pennsylvania 19096
Wynnewood, PA
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