Perceval S Aortic Heart Valve Study- North America

Stopped early · Not applicable

Conditions studied: Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence

In brief

To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Key facts

Study ID

NCT01810679

Run by

Sorin Group USA, Inc.

People needed

355

Starts

2013-04-01

Expected to finish

2018-04-01

Last updated by the study team

2016-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects of age >= 18 years.
• Subjects with aortic valve stenosis or steno-insufficiency.
• The subject is willing to sign the informed consent.
• The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
• 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.

You may not qualify if…

• The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.
• The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
• The subject has a previously implanted PERCEVAL valve that requires replacement.
• Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
• The subject has active endocarditis.
• Subjects with active myocarditis
• The subject is or will be participating in a concomitant research study of an investigational product.
• Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
• 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 patient.
• Subjects with known hypersensitivity to nickel alloys.
• The subject is undergoing renal dialysis for chronic renal failure or has 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.
• Subject is known to be noncompliant or is unlikely to complete the study.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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