On-X Aortic Heart Valve for Coagulopathy

Not currently recruiting at 23 trial locations

Overseen By Yael Goode, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: On-X Life Technologies, Inc.

Must be taking: Anticoagulants

Disqualifiers: Other prosthetic valves, Thromboembolic events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the On-X Aortic Heart Valve for patients taking a lower dose of the blood thinner warfarin. The goal is to determine if this approach reduces issues such as bleeding or blood clots over five years. It suits adults who received an On-X aortic valve within the past year and have a life expectancy of at least five more years. As a Phase 4 trial, it involves an FDA-approved treatment, providing insights into its benefits for a broader patient population.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the On-X Aortic Heart Valve replacement is safe?

Research shows that the On-X Aortic Heart Valve replacement is well-tolerated by patients. Studies have confirmed the safety of this heart valve for surgeries. It holds approval from the FDA, Health Canada, and has the CE Mark, indicating it meets strict safety standards in the U.S., Canada, and Europe.

In studies, patients using the On-X valve showed no significant difference in major bleeding or blood vessel blockages compared to expectations. This suggests the valve does not increase the risk of these issues. The valve is also proven safer with a lower dose of blood thinner, targeting an International Normalized Ratio (INR) of 1.5 to 2.0, potentially reducing bleeding problems for patients.

Overall, the On-X Aortic Heart Valve has a strong safety record, offering reassurance to potential trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the On-X Aortic Heart Valve replacement because it allows patients to maintain a lower dose of warfarin with an INR target of 1.5 to 2.0. This is significant because standard mechanical heart valves typically require higher doses of warfarin to prevent blood clots, leading to a greater risk of bleeding complications. The potential for home monitoring also offers patients more convenience and control over their treatment. These features could improve safety and quality of life for patients needing aortic valve replacements.

What evidence suggests that the On-X Aortic Heart Valve replacement is effective for reducing bleeding and thromboembolism?

Research has shown that the On-X Aortic Heart Valve, under study in this trial, performs well for aortic valve replacement. Studies have found that 95.2% of patients with this valve survive after two years. The valve also results in fewer blood clots and less bleeding compared to other aortic valves. After seven years, patients report good heart function and blood flow through the valve. Overall, the On-X valve is considered safe and effective for aortic valve replacement. ^{1 6 7 8 9}

Who Is on the Research Team?

Goeff Tsang, MBChB

Principal Investigator

Southampton University

Are You a Good Fit for This Trial?

Inclusion Criteria

Life expectancy of at least 5 years.

Patients whose operation occurred within the year prior to recruitment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Patients are under standard anticoagulation (INR 2.5) for at least 3 months before initiation of low dose anticoagulation treatment

3 months

Treatment

Participants receive low dose warfarin anticoagulation with an INR target of 1.5 to 2.0, with or without home monitoring

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• On-X Aortic Heart Valve replacement

How Is the Trial Designed?

Group I: On-X Aortic Heart Valve replacement Experimental Treatment 1 Intervention

Patients with On-X Aortic Valve maintained on low dose warfarin anticoagulation with an INR target of 1.5 to 2.0, with or without home monitoring.

Who Is Running the Clinical Trial?

On-X Life Technologies, Inc.

Lead Sponsor

Trials

4

Recruited

2,400+

North American Science Associates Inc.

Collaborator

Trials

3

Recruited

1,900+

Citations

1.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf

Summary of Safety and Effectiveness Data On-X® Prosthetic ...

effectiveness of the valve in aortic valve replacement. ... The animal studies show that the On-X® Prosthetic Heart Valve is safe for valve replacement.

2.

annalsthoracicsurgery.org

annalsthoracicsurgery.org/article/S0003-4975(02)03968-1/fulltext

The On-X prosthetic heart valve at five years 1

The actuarial freedom from death at 2 years (Fig 2) in the study was 95.2% ± 1.4% in AVR patients and 92.4% ± 2.0% in MVR, and the freedom from valve-related or ...

3.

investors.artivion.com

investors.artivion.com/news-releases/news-release-details/artivion-announces-presentation-new-clinical-data-x-aortic-heart

Artivion Announces Presentation of New Clinical Data for On ...

5-year real-world safety and efficacy data from the On-X Aortic Heart Valve Low INR post-market study that demonstrate even better patient outcomes.

4.

surgery.med.ufl.edu

surgery.med.ufl.edu/wordpress/files/2025/07/Seven-year-outcomes-following-aortic-valve-replacement.pdf

Seven-year outcomes following aortic valve replacement with ...

Effectiveness end points included New York Heart Association. (NYHA) functional class and valve hemodynamic performance, including mean transvalvular ...

5.

onxlti.com

onxlti.com/clinical-update-thirty-four-on-x-heart-valves-outperforms/

Clinical Update Thirty-Four: On-X Heart Valve Outperform

The On-X aortic valve average thromboembolic and hemorrhage rates were lower than the average aortic tissue valve results along with those for reoperation and ...

6.

onxlti.com

onxlti.com/wp-content/uploads/2019/05/010122103A-On-X-IFU-Booklet-English-Website-Version.pdf

Prosthetic Heart Valve

designed to study the safety and effectiveness of the valve in aortic and mitral valve replacement. Patients requiring isolated aortic heart valve replacement.

7.

artivion.com

artivion.com/product/on-x-aortic/

On-X® Aortic Heart Valve

The only aortic mechanical valve with FDA, Health Canada, and CE Mark approval for Low INR of 1.5 – 2.0.1*; Clinically proven to be safer with less ...

8.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf

Prosthetic Heart Valve, Models ONXM and ONXMC Table of ...

On-X. ®. Prosthetic Heart Valve is safe and effective for the replacement of native or prosthetic mitral valves. 12. PANEL RECOMMENDATIONS. In accordance with ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12342359/

Major Bleeding and Thromboembolic Events with the On-X ...

In this nationwide cohort study, we observed no significant difference in major bleeding or thromboembolic events in patients with the On-X ...