Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a lower warfarin dose make aortic valve replacement safer?

NCT ID NCT02677974

Disease control Sponsor: On-X Life Technologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study looks at whether people with an On-X mechanical aortic heart valve can safely take a lower dose of the blood thinner warfarin. The goal is to reduce bleeding complications while still preventing dangerous blood clots. Researchers will follow 510 adults for up to 5 years after valve replacement surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
On-X Aortic Heart Valve replacement with low dose warfarin
What this could lead to
If successful, this could show that a lower warfarin dose safely reduces bleeding risk while still preventing clots in people with an On-X aortic valve.
What could go wrong
This is an observational registry, not a randomized trial, so results may be influenced by patient differences. Lower warfarin doses might increase the risk of valve clots or strokes in some patients.
Why investors are watching

Artivion, through its On-X Life Technologies unit, is running a 510-patient registry study to see if its aortic heart valve works safely with a lower dose of the blood thinner warfarin than standard. The trial tracks bleeding, valve clots, and valve thrombosis over five years at a lower INR target. For a small-cap company, this readout matters because the valve is a core product, and a positive result could support the current dosing label and strengthen its position in heart valve surgery.

If it works: If the lower-dose warfarin keeps adverse event rates in line with earlier trial results, Artivion could use that data to reinforce the valve's safety profile and potentially expand its use among patients who need fewer blood-thinner complications. That could help sales of the On-X valve, a key product for the company.

If it fails: If the study shows higher bleeding or clot rates at the lower dose, or if enrollment or follow-up drags, Artivion may face regulatory questions or a need to revise dosing guidance. Clinical trials often fail or produce mixed results, and a negative outcome could hurt confidence in the valve's main selling point.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

510 people

The number who actually took part.

Started

Nov 2015

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with On-X aortic heart valve replacements implanted within the prior year.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients (age 18 years or older) who have only an On-X aortic prosthetic heart valve (ONXA, ONXAE, ONXAC, ONXACE, ONXAN, ONXANE) implant, without or without concomitant procedures, and agreed to participate in the registry. 2. Life expectancy of at least 5 years. 3. Patients whose operation occurred within the year prior to recruitment. Exclusion Criteria: 1. Patients having any other type of prosthetic valve implant (isolated or in combination with another valve(s)) or any On-X mitral valve; i.e. no mitral or multiple valve implants. 2. Patients with a prior history of arterial thromboembolic events, or who have such events or On-X valve thrombosis after AVR and prior to recruitment. 3. Death prior to discharge or recruitment. 4. Patients whose surgery predates enrollment by more than 1 year.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

aortic valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thrombotic and bleeding events

Contacts and locations

Locations

  • Arizona Cardiothoracic & Neurology

    Tucson, Arizona, 85718, United States

  • Baylor Scott & White - Plano

    Plano, Texas, 75093, United States

  • Blackpool Victoria Hospital

    Blackpool, United Kingdom

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Franciscan St. Francis

    Indianapolis, Indiana, 46237, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Hull & East Yorkshire Hospitals

    Hull, United Kingdom

  • John Radcliffe Hospital

    Oxford, United Kingdom

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • MultiCare Health System

    Tacoma, Washington, 98405, United States

  • Providence St. Vincent

    Portland, Oregon, 97213, United States

  • Sanford Medical Center

    Fargo, North Dakota, 58122, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • St. Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • The Lindner Center at The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • University Hospital Southampton

    Southampton, SO16 6YD, United Kingdom

  • University of Calgary

    Calgary, Alberta, Canada

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Texas Health Science Center - Houston

    Houston, Texas, 77030, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • Victoria Heart Institute

    Victoria, British Columbia, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.