Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
355 participants
INTERVENTIONAL
2013-04-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Perceval S Aortic Heart Valve
Treatment with the Perceval S Aortic Heart Valve
Perceval S Aortic Heart Valve
Perceval S Sutureless Aortic Heart Valve
Interventions
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Perceval S Aortic Heart Valve
Perceval S Sutureless Aortic Heart Valve
Eligibility Criteria
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Inclusion Criteria
2. Subjects with aortic valve stenosis or steno-insufficiency.
3. The subject is willing to sign the informed consent.
4. The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
5. 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).
6. Subject will be available to the investigator(s) for postoperative follow-up beyond one year.
Exclusion Criteria
2. The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
3. The subject has a previously implanted PERCEVAL valve that requires replacement.
4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
5. The subject has active endocarditis.
6. Subjects with active myocarditis
7. The subject is or will be participating in a concomitant research study of an investigational product.
8. Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
9. The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
10. 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 patient.
11. Subjects with known hypersensitivity to nickel alloys.
12. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
13. 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.
14. Subject is known to be noncompliant or is unlikely to complete the study.
15. Subjects with an aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is \> 1.3.
18 Years
ALL
No
Sponsors
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Sorin Group USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rakesh Suri, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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East Alabama Medical Center
Opelika, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Colorado Denver
Aurora, Colorado, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Oakwood Hospital
Dearborn, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Presbyterian - Weill Cornell Medical Center
New York, New York, United States
Montefiore Medical Center/Albert Einstein College of Medicine
New York, New York, United States
Lenox Hill/NS-LIJ
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Cardiothoracic and Vascluar Surgeons
Austin, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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G120053
Identifier Type: -
Identifier Source: org_study_id