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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Valve Disease
• Intervention / Treatment: Device: 17mm aortic valve (On-X ); Device: 23mm mitral valve (On-X)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • Mayaguez, Puerto Rico, 00681
    • Mayaguez Medical Center
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinico Provincial
  • Salamanca, Spain, 37008
    • University Hospital Salamanca
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Children's Heart Center Nevada
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma/Children's Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Tacoma, Washington, United States, 98415
      • Mary Bridge Children's - Tacoma General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 17mm On-X Aortic Heart Valve; Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.	Device: 17mm aortic valve (On-X ); Heart aortic valve replacement surgery: 17mm Aortic; Other Names: On-X prosthetic heart valve
Experimental: 23mm On-X Mitral Heart Valve; Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve. Enrollment into the 23mm On-X mitral arm has been terminated.	Device: 23mm mitral valve (On-X); Heart mitral valve replacement surgery: 23mm Mitral; Other Names: On-X prosthetic heart valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Valve Related Adverse Events at 1 Year	Number of subjects with a valve related adverse event at 1 year.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of Valve Thrombosis at 1 Year	Number of subjects with a diagnosis of Valve Thrombosis at 1 year	1-year

Collaborators and Investigators

• Sponsor: On-X Life Technologies, Inc.
• Investigators: Study Chair: Sidney Levitsky, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2011
• Primary Completion (Actual): December 7, 2018
• Study Completion (Actual): December 7, 2018

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimated): March 18, 2013

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: heart valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2010-01 (internal number); G120115 (Other Identifier: FDA)