Not yet recruitingOBSERVATIONAL

Mitral Valve Repair With the Chord-X System: A Long Term Evaluation

This study, called "Mitral Valve Repair With the Chord-X System: A Long Term Evaluation," aims to understand the long-term safety and effectiveness of the Chord-X System for people with a leaky heart valve, known as mitral regurgitation. The Chord-X System is a special device used during heart surgery to fix the leaky part of the valve. Researchers will collect information from patients who have already had this device implanted, as well as data from new patients over a period of up to 10 years. The main goal is to gather more evidence to help doctors make the best decisions for future patients needing this type of heart valve repair, ultimately improving patient care.

At a glance

Status

Not yet recruiting

Sponsor

Artivion Inc.

Enrolment target

110

Start

01 Jun 2026

Estimated completion

01 Jun 2034

Mitral Regurgitation (MR)

What is this study about?

This study is all about understanding how a medical device called the Chord-X System works in the long run for people who have a condition called mitral regurgitation. This means that a valve in your heart, called the mitral valve, isn't closing properly, causing blood to leak backwards. The Chord-X System is a special tool used by surgeons during an operation to repair this leaky valve, essentially replacing the faulty 'strings' that help the valve leaflets open and close.

The main aim of this research is to collect information from patients who have had this surgery. Researchers want to see how safe and effective the Chord-X System is over a long period, up to 10 years. By gathering this detailed information from many patients, they can learn more about how well the device performs in real-world situations. This helps improve our understanding and can lead to better care for people with mitral regurgitation in the future.

This study will look at records from past patients and also follow up with new patients. The information collected will help doctors ensure that people with a leaky mitral valve receive the most effective and safest treatment possible. It's about building a strong foundation of evidence to support the use of this repair system.

Key takeaways

Study examines the Chord-X System for leaky heart valves.
Aims to understand long-term safety and performance.
Collects data from patients who've already had the surgery.
Follows patients for up to 10 years.
No new treatments; focuses on existing medical records and routine visits.
Findings could improve future heart valve repair methods.

Who may be eligible?

To be part of this study, you might be eligible if you've had a type of heart surgery called a mitral valve repair, where the Chord-X System was used. This surgery needed to have happened from January 2022 onwards, and it must have been a standard procedure for your condition, not an experimental one.

You would also need to be willing and able to attend follow-up appointments for up to 10 years after your surgery. The study will also review your past medical history related to your heart condition and surgery.

You wouldn't be able to join if your Chord-X System was used in a non-standard way, or if you had your surgery before January 2022. Additionally, if you've had previous mitral valve surgery, underwent multiple valve repairs, or had certain other heart conditions or emergency surgery, you likely 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.

Did you have mitral valve repair surgery using the Chord-X System?
Was your surgery performed from January 2022 onwards?
Are you able and willing to attend your routine follow-up appointments for up to 10 years?
Did you have this specific surgery as a standard treatment, not an experimental one?
Have you not had previous mitral valve surgery?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be undergoing any new procedures or treatments specifically for the research. Instead, the study will involve collecting information about your health. Researchers will look at your past medical history and details of your mitral valve repair surgery where the Chord-X System was used. This includes results of any follow-up examinations you've had since your operation.

You will also be asked to attend your regularly scheduled follow-up appointments at the clinic, as you would normally, and the study will collect information from these visits. The total duration of data collection for each participant can be up to 10 years from your surgery date, depending on when your operation took place and your individual follow-up schedule.

Potential risks and benefits

Taking part in this study primarily involves sharing your existing medical information and attending your routine follow-up appointments, so there are no new medical treatments or procedures involved. The potential benefit is that the information gathered from your experience, alongside others, will help doctors better understand the long-term safety and performance of the Chord-X System, which could improve care for future patients. There are minimal direct risks to you, as no new interventions are being performed. You are free to withdraw your consent to participate at any time without affecting your medical care.

Locations (4)

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

St. Elizabeth Healthcare
Verified postcode
Edgewood, United States
Monasterio Foundation Heart Hospital
Verified postcode
Massa, Italy
Blackpool Victoria Hospital
Verified postcode
Blackpool, United Kingdom
The James Cook University Hospital
Verified postcode
Middlesbrough, United Kingdom

Common questions

What is mitral regurgitation?

Mitral regurgitation is a condition where a heart valve (the mitral valve) doesn't close completely, allowing blood to leak backwards.

What is the Chord-X System?

It's a special medical device used during heart surgery to repair a leaky mitral valve, replacing faulty 'strings' that help the valve work.

Will I receive new treatment in this study?

No, this study only collects information from patients who have already had the Chord-X System implanted, often as part of their routine care.

How long will I be involved in the study?

Data will be collected from your records and routine follow-up visits for up to 10 years after your surgery.

What is the purpose of this study?

The study aims to gather more long-term evidence on how safe and effective the Chord-X System is to improve future patient care.

How to find out more

Priya Patel

priya.patel@artivion.com 16789843952 Official trial record

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