MitraClip EXPAND G4 Study
This study is for people who have a heart condition called mitral regurgitation, which means a valve in their heart is leaky. Doctors are using a new version of a device called MitraClip G4 to help fix this. This study is checking how safe and effective this new MitraClip G4 device is for patients after it has been approved for use. Around 1,100 patients across different countries will take part. Researchers will monitor these patients for up to five years after they receive the device, checking on their heart health and general well-being. The study wants to make sure the G4 device is working as expected and is safe for everyone.
At a glance
Results
Results from this study
Posted January 2025Results have been published for this study.
What is this study about?
This study is focused on a heart problem called mitral regurgitation. This happens when one of your heart valves, the mitral valve, doesn't close properly, causing blood to leak backward. This can make your heart work harder and lead to symptoms like breathlessness or tiredness.
To help with this, doctors can use a device called a MitraClip. This small clip helps the leaky valve close more effectively. This study is looking at the newest version of this device, called the MitraClip G4 System. It's a 'post-market' study, which means the device is already approved for use, and researchers are now carefully watching how it performs in many more patients in real-world settings.
The main goal is to confirm that the MitraClip G4 is both safe and works well for people with mitral regurgitation. They will gather information from many patients over several years to understand its long-term effects and make sure it's offering the best possible care.
Key takeaways
- This study is about a new MitraClip device (G4) for leaky heart valves.
- It aims to confirm the device's safety and effectiveness in many patients.
- You'll have regular follow-up appointments, including heart scans, for up to 5 years.
- Participation is for people already scheduled for MitraClip treatment.
- The study helps doctors understand the long-term benefits and risks of the G4 device.
Who may be eligible?
To be part of this study, you would first need to be planned to receive the MitraClip device because your doctor thinks it's the right treatment for your leaky heart valve based on current guidelines.
You also need to agree to participate in the study. This means you understand what's involved and give your permission to have your health information collected for the research.
However, you wouldn't be able to join if you are already taking part in another medical study that might affect the results or how this study is carried out.
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.
- Am I scheduled to receive a MitraClip for a leaky heart valve?
- Am I willing to have my health information used for this research?
- Am I currently in any other medical studies that might overlap?
- Do I understand what's involved in the follow-up appointments?
What does participation involve?
If you join this study, you will receive the MitraClip G4 device as part of your treatment, just like any other patient who needs it. After the procedure, doctors will keep a close eye on your health and check how your heart valve is doing.
You will have check-ups, which include heart scans (called echocardiograms), when you leave the hospital, and then again after 30 days, 1 year, and 5 years. There will also be other check-ups by phone call at 6 months, and in person at 2, 3, and 4 years. The total time you'll be involved in the study's follow-up is up to 5 years.
Potential risks and benefits
Locations (63)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States
- Cardiology Associates of Mobile, Inc.Verified postcodeMobile, United States
- Arkansas Heart HospitalVerified postcodeLittle Rock, United States
- Scripps HealthVerified postcodeLa Jolla, United States
- University of California - Davis Medical CenterVerified postcodeSacramento, United States
- Los Robles Regional Medical CenterVerified postcodeThousand Oaks, United States
- Cardiology Associates of Fairfield County, PCVerified postcodeNorwalk, United States
- NCH Healthcare SystemVerified postcodeNaples, United States
- Northshore University Health SystemVerified postcodeEvanston, United States
- Prairie Education & ResearchVerified postcodeSpringfield, United States
- Via ChristiVerified postcodeWichita, United States
- Abbott Northwestern HospitalVerified postcodeMinneapolis, United States
Common questions
What is mitral regurgitation?
Mitral regurgitation is a condition where a heart valve, called the mitral valve, doesn't close completely, allowing blood to leak backwards in your heart.
What is a MitraClip?
A MitraClip is a small device that doctors can use to help a leaky mitral valve close better, which can improve blood flow in the heart.
Why is this study being done?
This study is being done to check the safety and how well a newer version of the MitraClip, called MitraClip G4, works in many patients after it's been approved for use.
How long will I be followed in the study?
If you join the study, you will be followed for up to 5 years with a mix of hospital visits, clinic appointments, and phone calls.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any point without it affecting your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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