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

Stopped early · Not applicable

Conditions studied: Heart Valve Disease

In brief

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.

Key facts

Study ID

NCT01812174

Run by

On-X Life Technologies, Inc.

People needed

20

Starts

2011-11-18

Expected to finish

2018-12-07

Last updated by the study team

2024-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Patients with a previous prosthetic valve, where it is not being replaced by a study valve, or patients requiring multiple valve replacement.
• 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.
• 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.
• Patients previously enrolled and implanted in this trial may not re-enter after withdrawal.
• Patients already enrolled in another investigational device or drug study (nor can enrolled patients be enrolled in other studies).
• 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.
• Patients with aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complication.
• Patients who are prisoners or mentally ill, and pediatric patients who are incapable of understanding their assent as judged by the principal investigator.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Maine Medical Center — Portland, Maine, United States
• Children's Heart Center Nevada — Las Vegas, Nevada, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• University of Oklahoma/Children's Hospital — Oklahoma City, Oklahoma, United States
• University of Virginia — Charlottesville, Virginia, United States
• Mary Bridge Children's - Tacoma General Hospital — Tacoma, Washington, United States
• Mayaguez Medical Center — Mayagüez, PR, Puerto Rico
• Hospital Clinico Provincial — Barcelona, Spain
• University Hospital Salamanca — Salamanca, Spain

Full record on ClinicalTrials.gov

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