Active not recruitingOBSERVATIONAL

On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

This study is for people who have received a special type of heart valve called an On-X Aortic Heart Valve. Doctors are looking at patients who are taking a blood-thinning medication called warfarin, but at a slightly lower dose than usual. The main goal is to understand how often people experience problems like bleeding or blood clots around the new heart valve over five years. This information will help doctors ensure patients receive the safest and most effective care after their heart valve replacement surgery. It's an important step in making sure the On-X valve, with this specific blood-thinner dose, is working well for patients.

At a glance

Status

Active not recruiting

Sponsor

On-X Life Technologies, Inc.

Enrolment target

510

Start

10 Nov 2015

Estimated completion

01 Aug 2027

Thrombotic and Bleeding Events

What is this study about?

If you've had an On-X Aortic Heart Valve fitted, this study is designed to learn more about your health and how your new valve is working. After a heart valve replacement, it's common to take a blood-thinning medicine like warfarin to prevent blood clots from forming on the new valve. This study is specifically looking at patients who take a slightly lower dose of warfarin than what is usually prescribed for other types of heart valves. The lower dose aims to reduce the risk of bleeding, while still preventing dangerous clots.

Over the next five years, doctors will carefully watch how patients in the study are doing. They will record any instances of bleeding or blood clots to understand how safe and effective this lower dose of warfarin is with your particular heart valve. Your doctors will follow your progress during your regular check-ups, so you won't need extra tests just for this study.

The purpose is to gather important information from many patients to help doctors make the best decisions for people with an On-X Aortic Heart Valve in the future. By joining, you're helping medical science improve care for others.

Key takeaways

Study focuses on the On-X Aortic Heart Valve.
Investigates a lower dose of blood-thinning medication (warfarin).
Aims to understand bleeding and clotting risks over 5 years.
Uses routine medical data, no extra tests.
Patients also take daily low-dose aspirin.

Who may be eligible?

This study is looking for adults aged 18 or older who have had a new On-X Aortic Heart Valve fitted within the last year. It's important that this is the only artificial heart valve you have; if you have other artificial valves (like a mitral valve) or another type of valve, you wouldn't be able to join.

To be included, you should generally be in good health with an expected life span of at least five more years. Unfortunately, if you've already had serious blood clots or valve issues after your surgery but before the study starts, or if you sadly passed away before being able to join, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you receive an On-X Aortic Heart Valve within the last year?
Is the On-X Aortic Heart Valve your only artificial heart valve?
Do you not have a history of serious blood clots or valve issues after your surgery but before joining?
Are you generally expected to live at least 5 more years?

Answer every question to see your result.

What does participation involve?

If you join this study, it won't involve any extra appointments or special tests beyond your usual check-ups. You'll continue with your regular follow-up visits after your heart valve surgery. During these visits, your medical team will collect information about your health, including how you're responding to your blood-thinning medication (warfarin) and if you've experienced any problems like bleeding or blood clots. This information will be added to a secure online database.

Initially, for at least three months after your surgery, you'll be on a standard dose of warfarin. After this period, if suitable, you'll transition to a slightly lower dose of warfarin. You will also be prescribed a daily low-dose aspirin, often called 'baby' aspirin. You'll be followed for five years, with data collected during your routine medical care to see how you're doing with the low-dose warfarin and aspirin combination.

Potential risks and benefits

Participating in this study directly benefits others by helping doctors learn more about the safest and most effective treatment for people with an On-X Aortic Heart Valve. There are no additional risks beyond those in your standard medical care, as the study uses information collected during your routine appointments and involves a lower dose of warfarin, which aims to reduce bleeding risk. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (23)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arizona Cardiothoracic & Neurology
Verified postcode
Tucson, United States
Hartford Hospital
Verified postcode
Hartford, United States
Franciscan St. Francis
Verified postcode
Indianapolis, United States
Maine Medical Center
Verified postcode
Portland, United States
Sanford Medical Center
Verified postcode
Fargo, United States
The Lindner Center at The Christ Hospital
Verified postcode
Cincinnati, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Providence St. Vincent
Verified postcode
Portland, United States
University of Texas Southwestern
Verified postcode
Dallas, United States
University of Texas Health Science Center - Houston
Verified postcode
Houston, United States
Baylor Scott & White - Plano
Verified postcode
Plano, United States
Sentara Norfolk General Hospital
Verified postcode
Norfolk, United States

Common questions

What is an On-X Aortic Heart Valve?

It's a specific type of artificial heart valve used to replace a diseased or damaged aortic valve in your heart.

What is warfarin?

Warfarin is a medicine that helps to thin your blood, preventing harmful clots from forming, especially on artificial heart valves.

Why a lower dose of warfarin?

The study is investigating if a slightly lower dose of warfarin can still effectively prevent blood clots while also reducing the risk of bleeding in people with this specific valve.

Will I have extra doctor visits?

No, you won't have any extra visits. Information for the study will be collected during your normal follow-up appointments after your heart surgery.

How long does the study last for each patient?

You will be followed for five years from the time you join the study.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.