On-X Heart Valve - 17mm Aortic and 23mm Mitral



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/28/2017
Start Date:January 2012
End Date:June 2020
Contact:Stephen Ottmers, PhD
Email:Ottmers.Stephen@cryolife.com
Phone:512-339-8000

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This study examines the hemodynamic and hemolytic properties of two additional smaller size
valves to the On-X line of valves already approved by FDA.

The purpose of the study is to assess the safety and efficacy of the 17mm On-X Aortic
Prosthetic Heart Valve and the 23mm On-X Mitral Prosthetic Heart Valve when used to replace
diseased aortic or mitral valves in human subjects.

The On-X 17mm aortic and 23mm mitral valves will be implanted in approximately 20 and at
least 15 patients per size and each will be followed for at least 1 year. Patients will be
any age and will require these size valves as determined in surgery but will be recruited
prior to surgery based on results of preoperative screening tests.

Inclusion Criteria:

1. Patients of any age; unless waived by local IRB assent of the patient and in all cases
consent of parent or legally authorized representative is required if a patient is
under the age of majority and not legally emancipated.

2. Patients who are sufficiently ill to warrant replacement of their diseased natural or
prosthetic valve, based on standard cardiovascular diagnostic workups.

3. Patients who are in sufficient satisfactory condition, based on the physical exam and
investigator's experience, to be an average or better operative risk, (i.e., likely to
survive one year postoperatively).

4. Patients who require an isolated aortic valve replacement size 17 mm or isolated
mitral valve replacement size 23mm.

5. Patients who are geographically stable and willing to return to the implanting center
for follow-up visits.

6. Patients or legally authorized representatives who are adequately informed of their
participation in the clinical study and what will be required of them in order to
comply with the protocol.

7. Patients requiring concomitant cardiovascular surgery, such as coronary bypass may be
included in the study.

Exclusion Criteria:

1. Patients who are pregnant, planning to become pregnant or are lactating. 2 Patients who
have a noncardiac progressive disease, which in the investigator's experience produces an
unacceptable increased risk to the patient.

3 Patients who have a documented history of substance (drug or alcohol) abuse or are prison
inmates.

4. Patients with a previous prosthetic valve, where it is not being replaced by a study
valve, or patients requiring multiple valve replacement.

5. Patients with active endocarditis or active myocarditis. 6 Patients who require
tricuspid or pulmonic valve replacement. 7. Patients who have not agreed to return for the
required number of follow-up visits or who are geographically unavailable for follow-up.

8. Patients who cannot be maintained on long-term anticoagulant therapy. 9. Patients with
non-cardiac illness resulting in a life expectancy of less than 1-year.

10. Patients previously enrolled and implanted in this trial may not re-enter after
withdrawal.

11. Patients already enrolled in another investigational device or drug study (nor can
enrolled patients be enrolled in other studies).

12. Patients with acute preoperative neurological deficit, myocardial infarction, or
cardiac event who have not returned to baseline for at least 30-days prior to enrollment.

13. Patients with aortic aneurysm or other medical condition that creates a higher than
usual risk of surgical complication.

14. Patients who are prisoners or mentally ill, and pediatric patients who are incapable of
understanding their assent as judged by the principal investigator.
We found this trial at
11
sites
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Reed Quinn, MD
Phone: 207-662-1489
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Patrick McConnell, MD
Phone: 614-355-6788
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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Ann Arbor, Michigan 48167
Principal Investigator: Ming-Sing Si, MD
Phone: 734-763-6109
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Ann Arbor, MI
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: James Gangemi, MD
Phone: 434-924-9061
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cincinnati, Ohio 45267
Principal Investigator: David Morales, MD
Phone: 513-803-9150
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Cincinnati, OH
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Dallas, Texas 75390
Principal Investigator: Timothy Pirolli, MD
Phone: 214-456-5000
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Dallas, TX
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Las Vegas, Nevada 89109
Principal Investigator: Michael Ciccolo, MD
Phone: 702-732-1290
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Las Vegas, NV
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Mayaguez, 00681
Principal Investigator: Raul Garcia-Rinaldi, MD
Phone: 787-538-0019
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2500 Grant Rd
Mountain View, California 94040
(650) 940-7000
Principal Investigator: Vincent Gaudiani
Phone: 650-962-4566
El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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Oklahoma City, Oklahoma 73126
Principal Investigator: Harold Burkhart, MD
Phone: 405-271-2601
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Oklahoma City, OK
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Tacoma, Washington 98415
Principal Investigator: Dennis Nichols, MD
Phone: 253-403-7257
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Tacoma, WA
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