RecruitingOBSERVATIONAL

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

This study, called CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE), is a worldwide effort to understand the real-world experiences of patients receiving a transcatheter mitral valve replacement (TMVR). This is a less invasive procedure for a leaky heart valve, known as mitral regurgitation. The study collects information on how patients do after the procedure, gathering data from hospitals that perform TMVR. While it mainly focuses on those who have the TMVR procedure, it has also looked at some patients in the past who were considered for TMVR but went on to have other treatments, such as traditional surgery or different keyhole procedures. The goal is to see how effective TMVR is in everyday medical practice.

At a glance

Status

Recruiting

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

1,000

Start

01 Nov 2020

Estimated completion

31 Dec 2030

Mitral Regurgitation Mitral Valve Disease Mitral Annular Calcification

What is this study about?

This study, called CHOICE, is gathering information about a specific heart condition called mitral regurgitation. This happens when the mitral valve in your heart, which controls blood flow, doesn't close properly, causing blood to leak backward. This can make your heart work harder and lead to symptoms like breathlessness.

The study focuses on a procedure called transcatheter mitral valve replacement (TMVR). This is a less invasive way to treat the leaky valve, often performed using a catheter (a thin tube) inserted into a blood vessel. Instead of open-heart surgery, a new valve is delivered and implanted through this catheter. The CHOICE study is a registry, meaning it collects information from many hospitals around the world about patients who have had this TMVR procedure.

The main aim is to understand how well patients do after TMVR in real-world settings. By collecting data on many patients, doctors can learn more about the procedure's success, any potential issues, and how it compares to other treatments. This information helps improve care for future patients with mitral regurgitation.

Key takeaways

This study helps understand a keyhole heart valve procedure called TMVR.
It collects information from many hospitals around the world.
The focus is on how patients with leaky heart valves (mitral regurgitation) do after TMVR.
It's about real-world results, not an experimental treatment.
The information gathered aims to improve future care for heart patients.

Who may be eligible?

To be included in this study, patients typically have been diagnosed with a significant leak in their mitral heart valve and have undergone a careful check-up to see if the keyhole valve replacement (TMVR) procedure is suitable for them.

The study also needs to have detailed ultrasound scans of their heart from before and after any treatment, including the TMVR procedure. To make sure the information is useful, patients need to have had at least 30 days of follow-up care after their procedure.

Anyone under the age of 18 is not included in this study. Otherwise, both men and women of any adult age are eligible if they meet the other criteria.

Quick self-check

Do you have a significant leaky heart valve?
Have you been assessed to see if keyhole valve replacement (TMVR) is right for you?
Are you 18 years old or older?
Do you have heart scan (echo) information available from before and after your treatment?
Have you had at least 30 days of follow-up care after your procedure?

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

What does participation involve?

As a registry study, your participation would involve your medical information, gathered during your routine hospital care for mitral valve issues and TMVR, being collected and stored for research purposes. This typically includes details from your examinations, heart scans (echos), and follow-up appointments. You wouldn't be asked to undergo any extra tests or visits specifically for the study. The study looks at your health outcomes for at least 30 days after your procedure, using data already collected as part of your care. The specific duration beyond 30 days depends on how long your hospital routinely follows up with patients post-procedure.

Potential risks and benefits

Participating in a registry study like this generally carries very low risk, as it mainly involves the collection and analysis of existing medical records. There are no additional procedures or interventions involved. The potential benefit is that the information gathered from your and many other patients' experiences will help doctors better understand the effectiveness and outcomes of TMVR, ultimately improving care for future patients with similar heart conditions. You always have the right to withdraw your consent for your data to be used in the study at any time, without affecting your medical care.

Locations (43)

Tucson Medical Center
Tucson, United States· Recruiting
Cedars-Sinai Medical Center, Los Angeles
Los Angeles, United States· Recruiting
Tampa General Hospital
Tampa, United States· Recruiting
Brigham and Women's Hospital
Boston, United States· Recruiting
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, United States· Recruiting
Morristown Medical Center
Morristown, United States· Recruiting
Montefiore Medical Center
New York, United States· Recruiting
Oklahoma Heart Hospital
Oklahoma City, United States· Recruiting
Houston Methodist Hospital
Houston, United States· Recruiting
St Vincent's Hospital
Sydney, Australia· Recruiting
Medical University of Vienna
Vienna, Austria· Recruiting
Québec Heart and Lung Institute (Laval University)
Québec, Canada· Recruiting

+31 more sites — see the official record for the full list.

Common questions

What is mitral regurgitation?

Mitral regurgitation is a heart condition where the mitral valve doesn't close properly, causing blood to leak backwards in the heart. This can make your heart work harder.

What is TMVR?

TMVR stands for transcatheter mitral valve replacement. It's a less invasive procedure to replace a faulty mitral valve, often using a thin tube (catheter) inserted into a blood vessel.

Will I have extra tests for this study?

No, this study uses information collected during your routine medical care. You won't have any extra tests or appointments specifically for the study.

Who is running this study?

This is an investigator-initiated study, meaning it's led by doctors and researchers, rather than a pharmaceutical company, and involves many hospitals worldwide.

How does this study help patients?

By gathering real-world information on how patients do after TMVR, the study helps doctors understand the procedure better, which can lead to improved treatment and care for future patients with mitral valve disease.

How to find out more

Sebastian Ludwig, MD

se.ludwig@uke.de +494074100 Official trial record

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