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

Heart Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01812174
• Other study ID #: 2010-01
• Secondary ID: G120115
• Status: Terminated
• Phase: N/A
• Start date: November 18, 2011
• Est. completion date: December 7, 2018

Study information

• Verified date: February 2024
• Source: On-X Life Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 7, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

Device:
• 17mm aortic valve (On-X )
Heart aortic valve replacement surgery: 17mm Aortic
• 23mm mitral valve (On-X)
Heart mitral valve replacement surgery: 23mm Mitral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
On-X Life Technologies, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Valve Related Adverse Events at 1 Year	Number of subjects with a valve related adverse event at 1 year.	1 Year
Secondary	Diagnosis of Valve Thrombosis at 1 Year	Number of subjects with a diagnosis of Valve Thrombosis at 1 year	1-year