NCT01812174

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
3 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2018

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

February 1, 2024

Enrollment Period

7.1 years

First QC Date

March 12, 2013

Results QC Date

November 27, 2023

Last Update Submit

February 8, 2024

Conditions

Heart Valve Disease

Keywords

heart valve

Outcome Measures

Primary Outcomes (1)

  • Number of Valve Related Adverse Events at 1 Year

    Number of subjects with a valve related adverse event at 1 year.

    1 Year

Secondary Outcomes (1)

  • Diagnosis of Valve Thrombosis at 1 Year

    1-year

Study Arms (2)

17mm On-X Aortic Heart Valve

EXPERIMENTAL

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 )

23mm On-X Mitral Heart Valve

EXPERIMENTAL

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)

Interventions

17mm aortic valve (On-X )DEVICE

Heart aortic valve replacement surgery: 17mm Aortic

Also known as: On-X prosthetic heart valve
17mm On-X Aortic Heart Valve
23mm mitral valve (On-X)DEVICE

Heart mitral valve replacement surgery: 23mm Mitral

Also known as: On-X prosthetic heart valve
23mm On-X Mitral Heart Valve

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Children's Heart Center Nevada

Las Vegas, Nevada, 89109, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Oklahoma/Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Mary Bridge Children's - Tacoma General Hospital

Tacoma, Washington, 98415, United States

Location

Mayaguez Medical Center

Mayagüez, PR, 00681, Puerto Rico

Location

Hospital Clinico Provincial

Barcelona, 08036, Spain

Location

University Hospital Salamanca

Salamanca, 37008, Spain

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Erica Troup , Clinical Project Manager
Organization
Artivion, INC
erica.troup@artivion.com
706-409-5974

Study Officials

  • Sidney Levitsky, MD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 18, 2013

Study Start

November 18, 2011

Primary Completion

December 7, 2018

Study Completion

December 7, 2018

Last Updated

March 6, 2024

Results First Posted

March 6, 2024

Record last verified: 2024-02

Locations

US(7)PR(1)ES(2)