Perceval S Aortic Heart Valve Study- North America



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2013
End Date:April 2018
Contact:Marie T Steinbrink, MA
Email:marie.steinbrink@sorin.com
Phone:651-329-0351

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Clinical Investigation of the Perceval S Sutureless Heart Valve

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.

This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL
valve implanted in patients requiring aortic valve replacement. The study will be conducted
in a maximum of 25 centers in the United States. Patients will be evaluated at each of the
following time intervals:preoperative, at implant, in the early postoperative period, in the
late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11
and 13 months postoperatively), and annually until study completion. The duration of the
study is anticipated to be 5 years.

Inclusion criteria:

1. Subjects of age >= 18 years.

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:

1. The subject has preexisting valve prosthesis or annuloplasty ring in the mitral,
pulmonic or tricuspid position.

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.
We found this trial at
22
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Eric Roselli, MD
Phone: 216-444-8774
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vinod Thourani, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1 Shircliff Way
Jacksonville, Florida 32204
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Jacksonville, FL
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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8900 North Kendall Drive
Miami, Florida 33176
Principal Investigator: Alvaro Montoya, MD
Phone: 786-596-6258
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Miami, FL
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Reed Quinn, M.D.
Phone: 207-662-1489
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Gabriel Aldea, MD
Phone: 206-897-5916
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Thomas Reece, MD
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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Austin, Texas 78756
Principal Investigator: William Kessler, MD
Phone: 512-651-8403
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Austin, TX
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Bartley Griffith, MD
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Gorav Ailawadi, MD
Phone: 434-243-0315
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
313.593.7000
Phone: 313-436-2439
Oakwood Hospital For more than 60 years, Oakwood Hospital - Dearborn (OH-D) has proudly served...
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Dearborn, MI
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Falls Church, Virginia 22042
Principal Investigator: Niv Ad, MD
Phone: 703-776-7071
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Falls Church, VA
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Indianapolis, Indiana 46260
Principal Investigator: David Heimansohn, MD
Phone: 317-583-7804
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Indianapolis, IN
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New York, New York 10065
Principal Investigator: Leonard Girardi, M.D.
Phone: 212-746-5194
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New York, New York 10467
Principal Investigator: Robert Michler, MD
Phone: 718-920-2221
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New York, New York 11075
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Opelika, Alabama 36801
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Opelika, AL
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Wilson Szeto, MD
Phone: 215-662-8480
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Rochester, Minnesota 55905
Principal Investigator: Alberto Pochettino, MD
Phone: 507-255-5027
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Rochester, MN
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Toledo, Ohio 43606
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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