Status:
TERMINATED
On-X Heart Valve - 17mm Aortic and 23mm Mitral
Lead Sponsor:
On-X Life Technologies, Inc.
Conditions:
Heart Valve Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
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.
Detailed Description
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 mit...
Eligibility Criteria
Inclusion
- 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.
- Patients who are sufficiently ill to warrant replacement of their diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups.
- 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).
- Patients who require an isolated aortic valve replacement size 17 mm or isolated mitral valve replacement size 23mm.
- Patients who are geographically stable and willing to return to the implanting center for follow-up visits.
- 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.
- Patients requiring concomitant cardiovascular surgery, such as coronary bypass may be included in the study.
Exclusion
- 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.
Key Trial Info
Start Date :
November 18 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01812174
Start Date
November 18 2011
End Date
December 7 2018
Last Update
March 6 2024
Active Locations (10)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Maine Medical Center
Portland, Maine, United States, 04102
3
Children's Heart Center Nevada
Las Vegas, Nevada, United States, 89109
4
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229