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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01812174
Recruitment Status : Recruiting
First Posted : March 18, 2013
Last Update Posted : September 26, 2017
Information provided by (Responsible Party):
On-X Life Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Heart Valve Disease Device: 17mm aortic valve (On-X ) Device: 23mm mitral valve (On-X) Not Applicable

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 and 23mm mitral valves will be implanted in approximately 20 and at least 15 patients per size and each will be followed for at least 1 year. Patients will be any age and will require these size valves as determined in surgery but will be recruited prior to surgery based on results of preoperative screening tests.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: On-X Heart Valve - 17mm Aortic and 23mm Mitral
Study Start Date : January 2012
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

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 Name: 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.
Device: 23mm mitral valve (On-X)
Heart mitral valve replacement surgery: 23mm Mitral
Other Name: On-X prosthetic heart valve

Primary Outcome Measures :
  1. Hemodynamics as a measure of performance [ Time Frame: 1-year ]
    Pressure gradient

Secondary Outcome Measures :
  1. Valve-related adverse events as a measure of safety [ Time Frame: 1-year ]
    Composite rate of thromboembolism, bleeding, structural dysfunction, endocarditis, non-structural dysfunction

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01812174

Contact: Stephen Ottmers, PhD 512-339-8000 ext 254
Contact: Gretchen Wilderspin, MS 678-290-4309

United States, California
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Contact: Janet Lamm    650-962-4566   
Contact: Ryan Schroeder    650-691-4894   
Principal Investigator: Vincent Gaudiani         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Betsey Gallant, BN    207-662-1489   
Principal Investigator: Reed Quinn, MD         
United States, Michigan
University of Michigan, C.S. Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Tammy Doman    734-763-6109   
Contact: Nichole Rottach   
Principal Investigator: Ming-Sing Si, MD         
Sub-Investigator: Richard Ohye, MD         
Sub-Investigator: Edward Bove, MD         
Sub-Investigator: Jennifer Romano, MD         
Sub-Investigator: Jimmy Lu, MD         
United States, Nevada
Children's Heart Center Nevada Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Michael Ciccolo, MD    702-732-1290   
Contact: Shalethia Turner    702-990-4812 ext 1601   
Principal Investigator: Michael Ciccolo, MD         
Sub-Investigator: Sergio Carrillo, MD         
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: David Morales, MD    513-803-9150   
Contact: Tricia Heile    513-803-5267   
Principal Investigator: David Morales, MD         
Sub-Investigator: Roosevelt Bryant, MD         
Sub-Investigator: Jonathan Byrnes, MD         
Sub-Investigator: Michael Taylor, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Pawel Kwiatkowski, MD    614-355-6788   
Contact: Patrick McConnell, MD    614-722-3102   
Principal Investigator: Patrick McConnell, MD         
United States, Oklahoma
University of Oklahoma/Children's Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Harold Burkhart, MD    405-271-2601   
Contact: Theresa Lander    405-271-2601   
Principal Investigator: Harold Burkhart, MD         
United States, Texas
University of Texas Southwestern Medical Center - Dallas Children's Recruiting
Dallas, Texas, United States, 75390
Contact: Timothy Pirolli, MD    214-456-5000   
Contact: Angela Bowling    214-456-2810   
Principal Investigator: Timothy Pirolli, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: James Gangemi, MD    434-924-9061   
Contact: Rachael Simon, BSN    434-2437653   
Principal Investigator: James Gangemi, MD         
United States, Washington
Mary Bridge Children's - Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98415
Contact: Dennis Nichols, MD    253-403-7257   
Contact: Janey Barnhart    253-403-7252   
Principal Investigator: Dennis Nichols, MD         
Puerto Rico
Mayaguez Medical Center Recruiting
Mayaguez, Puerto Rico, 00681
Contact: Raul Garcia-Rinaldi, MD    787-538-0019   
Principal Investigator: Raul Garcia-Rinaldi, MD         
Hospital Clinico Provincial Active, not recruiting
Barcelona, Spain, 08036
University Hospital Salamanca Active, not recruiting
Salamanca, Spain, 37008
Sponsors and Collaborators
On-X Life Technologies, Inc.
Study Chair: Sidney Levitsky, MD Beth Israel Deaconess Medical Center

Responsible Party: On-X Life Technologies, Inc. Identifier: NCT01812174     History of Changes
Other Study ID Numbers: 2010-01
G120115 ( Other Identifier: FDA )
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by On-X Life Technologies, Inc.:
heart valve

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases