Clinical trial NCT01812174: On-X Heart Valve - 17mm Aortic and 23mm Mitral
Official title: On-X Heart Valve - 17mm Aortic and 23mm Mitral
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Valve Disease
Keywords: heart valve
Lead sponsor: On-X Life Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in one arm are recipients of the 17mm On-X Aortic Valve. Patients in the second arm are recipients of the 23mm On-X Mitral Valve. Since double valve cases are exclusionary, these two arms are mutually exclusive and non-randomized.
Primary purpose: TREATMENT

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 mitral valves in human subjects.

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

Enrollment into the 23mm mitral arm of the study has been terminated.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Valve Related Adverse Events at 1 Year
timeFrame: 1 Year
Secondary outcomes:
measure: Diagnosis of Valve Thrombosis at 1 Year
timeFrame: 1-year
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Las Vegas
country: United States
facility: Children's Heart Center Nevada
state: Nevada
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma/Children's Hospital
state: Oklahoma
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Tacoma
country: United States
facility: Mary Bridge Children's - Tacoma General Hospital
state: Washington
city: Mayaguez
country: Puerto Rico
facility: Mayaguez Medical Center
city: Barcelona
country: Spain
facility: Hospital Clinico Provincial
city: Salamanca
country: Spain
facility: University Hospital Salamanca
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Sidney Levitsky, MD
role: STUDY_CHAIR
References: