Heart Valve DiseaseNCT01812174
On-X Heart Valve - 17mm Aortic and 23mm Mitral
A study testing 17mm aortic valve (On-X ) and 23mm mitral valve (On-X) in people with Heart Valve Disease, run by On-X Life Technologies, Inc. at 10 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- 17mm aortic valve (On-X ) and 23mm mitral valve (On-X)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 18 Nov 2011to 7 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
University of Virginia
Charlottesville, Virginia, 22908
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229
Children's Heart Center Nevada
Las Vegas, Nevada, 89109
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of Oklahoma/Children's Hospital
Oklahoma City, Oklahoma, 73104
Maine Medical Center
Portland, Maine, 04102
Mary Bridge Children's - Tacoma General Hospital
Tacoma, Washington, 98415
Spain2 sites
Hospital Clinico Provincial
Barcelona, 08036
University Hospital Salamanca
Salamanca, 37008
About this study
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.
Read the 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.
- Conditions
- Heart Valve Disease
- Being tested
- 17mm aortic valve (On-X ), 23mm mitral valve (On-X)
- Keywords
- heart valve
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17mm aortic valve (On-X )Device
Also called On-X prosthetic heart valve
Heart aortic valve replacement surgery: 17mm Aortic
23mm mitral valve (On-X)Device
Also called On-X prosthetic heart valve
Heart mitral valve replacement surgery: 23mm Mitral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 23mm mitral valve (On-X) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Valve Related Adverse Events at 1 Year
Number of subjects with a valve related adverse event at 1 year.
Measured: 1 Year
Secondary outcomes (1)
Diagnosis of Valve Thrombosis at 1 Year
Number of subjects with a diagnosis of Valve Thrombosis at 1 year
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study start18 Nov 2011
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Why it stopped: The study was terminated due to low/slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- On-X Life Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sidney Levitsky, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812174
- Sponsor's protocol ID
- 2010-01
- Other IDs
- G120115
- Status last verified
- Feb 2024
- First submitted
- 12 Mar 2013
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-X Heart Valve - 17mm Aortic and 23mm Mitral
- ClinicalTrials.gov ID
- NCT01812174
- Acronym / sponsor ID
- 2010-01
- Conditions
- Heart Valve Disease
- Keywords
- heart valve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to low/slow enrollment.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- On-X Life Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2011 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 17mm On-X Aortic Heart Valve | Experimental | Device: 17mm aortic valve (On-X )Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve. |
| 23mm On-X Mitral Heart Valve | Experimental | Device: 23mm mitral valve (On-X)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17mm aortic valve (On-X )Also: On-X prosthetic heart valveHeart aortic valve replacement surgery: 17mm Aortic | Device | 17mm On-X Aortic Heart Valve |
| 23mm mitral valve (On-X)Also: On-X prosthetic heart valveHeart mitral valve replacement surgery: 23mm Mitral | Device | 23mm On-X Mitral Heart Valve |
Primary outcome
Number of Valve Related Adverse Events at 1 Year
Time frame: 1 Year
Number of subjects with a valve related adverse event at 1 year.
1 secondary outcome
Diagnosis of Valve Thrombosis at 1 Year
Time frame: 1-year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidney Levitsky, MD study chair
Beth Israel Deaconess Medical Center
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 17mm aortic valve (On-X ) and 23mm mitral valve (On-X) in people with Heart Valve Disease, run by On-X Life Technologies, Inc. at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Spain, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Valve Related Adverse Events at 1 Year (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.