Active not recruitingOBSERVATIONAL

Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)

This study, called ASCEND, is observing patients who have received a new type of artificial heart valve called the On-X Aortic Prosthesis. This valve is used to replace a diseased, damaged, or poorly working natural heart valve. It's an important study because it helps us understand how safe and effective this particular heart valve is after it's been used in patients in their daily lives. Doctors simply gather information during patients' regular follow-up appointments. The aim is to make sure the valve is working well and to identify any potential issues over time. This information helps medical professionals and future patients make informed decisions about heart valve replacements.

At a glance

Status

Active not recruiting

Sponsor

JOTEC GmbH

Enrolment target

108

Start

20 Oct 2021

Estimated completion

31 Mar 2029

Aortic Valve Disease

What is this study about?

This study is called the ASCEND study, and it's looking at a specific type of artificial heart valve called the On-X Ascending Aortic Prosthesis (AAP). When someone has a heart valve that isn't working properly because it's diseased or damaged, doctors might recommend replacing it with an artificial one. This particular study is important because it's a 'post-market' study, which means it's happening after the valve has already been approved for use, allowing us to see how it performs in a real-world setting with many different patients.

The main goal is to check how safe and effective the On-X AAP valve is. We want to know if it works well over time and if there are any issues. Doctors who choose to use this valve for their patients will share information they collect during routine check-ups. This information includes how patients are feeling and how their new valve is performing. It's a way for us to gather more long-term experience with the valve.

Patients who take part will have their health information, collected during their regular care, used for the study. In Europe, patients will be asked to join before their surgery. In the US, patients can join either before or after their surgery. If a patient passes away after their implant, their medical information can still be included in the study once approved. This study is designed to follow patients for about five years after their surgery, gathering important details about their heart health.

Key takeaways

This study observes the safety and performance of the On-X heart valve.
Data is collected during your regular medical appointments.
Participation helps us learn more about how the valve works long-term.
You will receive standard medical care, not experimental treatments.
The study typically tracks patients for about five years after surgery.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, you must be at least 18 years old when you receive your On-X AAP heart valve. You'll also need to understand and sign a consent form, allowing your medical information to be used for the study. Importantly, you should be willing and able to attend follow-up appointments.

There are some reasons why you might not be able to join. For example, if you can't safely take blood-thinning medication (anticoagulation therapy) or if you have a current heart infection (endocarditis) at the time of your valve implant, you wouldn't be eligible. Also, if you're already in another study that might affect your blood thinners, that could exclude you.

Other reasons for not being able to participate include certain unusual heart conditions, or if your doctor believes your overall health or other personal circumstances would make it difficult for you to take part in the study's follow-up plan. If your doctor thinks you have less than three years to live, you also wouldn't be eligible. Finally, if the On-X AAP is implanted at the same time as certain other specific devices, you wouldn't be able to join this study.

Quick self-check

Are you 18 years of age or older?
Can you safely take blood-thinning medication?
Are you willing to attend routine follow-up appointments?
Do you not have an active heart infection currently?
Are you not involved in another study that might affect your blood thinners?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you participate in this study, the main involvement is allowing your doctors to share information from your routine care and follow-up appointments. You will not receive any new or different treatments because of the study; your doctor will still decide the best course of action for your health. The study simply collects information about patients who are already receiving the On-X AAP valve as part of their standard medical treatment.

For patients in Europe, you would typically agree to join the study before your surgery. In the US, you might join either before or after your surgery. There aren't any extra visits solely for the study. Instead, information will be gathered during your regular check-ups, specifically at the time of hospital discharge, and then around 12 and 60 months (1 and 5 years) after your surgery. Heart scans (echocardiograms) done at these times will also be reviewed by a special lab. The total duration of data collection for each patient will be about five years.

Potential risks and benefits

There are no direct medical risks from participating in this study itself, as it involves collecting information from your routine medical care, not receiving experimental treatments or procedures. The usual risks associated with your heart valve replacement surgery and recovery would still apply, but these happen as part of your standard medical treatment, not due to the study. A potential indirect benefit is contributing to the understanding of the On-X AAP valve, which could help future patients and medical professionals. You always have the right to withdraw your consent and stop participating in the study at any time.

Locations (11)

Geisinger Health System
Danville, United States
Baylor College of Medicine
Houston, United States
VCU Medical Center Main Hospital
Richmond, United States
Medizinische Hochschule Hannover (MHH)
Hanover, Germany
University Hospital Magdeburg
Magdeburg, Germany
Policlinico S. Orsola-Malpighi
Bologna, Italy
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Castle Hill Hospital
Cottingham, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Newcastle Freeman Hospital
Newcastle, United Kingdom

Common questions

What is the On-X Aortic Prosthesis?

It's a type of artificial heart valve used to replace a natural heart valve that isn't working correctly.

Why is this study being done?

The study aims to check how safe and effective the On-X valve is after it's been used in patients in real-life situations over time.

Will I get any special treatment if I join?

No, you will receive your usual medical care. The study just collects information from your routine follow-up appointments.

How long will I be part of the study?

The study will collect information about your health for about five years after your surgery.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time.

How to find out more

Official trial record

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