RecruitingOBSERVATIONAL

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

This is a study about two special devices called the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System. These devices are used to help people with a heart problem called mitral regurgitation, which means a valve in their heart is leaky. The study wants to check how safe these devices are and how well they work once they've been used in patients in the real world. Researchers will look at whether people's heart valve leak improves, if they feel better, and if their overall quality of life gets better after having the procedure with these devices.

At a glance

Status

Recruiting

Sponsor

Edwards Lifesciences

Enrolment target

1,000

Start

23 Aug 2019

Estimated completion

31 Mar 2031

Mitral Regurgitation Mitral Insufficiency

What is this study about?

Imagine your heart has a set of doors, called valves, that open and close to make sure blood flows in the right direction. One of these is the mitral valve. If this valve becomes leaky, it's called mitral regurgitation, and it means some blood flows backward, making your heart work harder. This can make you feel tired or short of breath.

Doctors can fix this leaky valve with a procedure that uses a special device. This study is focused on two devices called the Edwards PASCAL and Edwards PASCAL Precision systems. These are not new inventions, but procedures using them have been happening. This study is an important step where doctors are carefully watching patients who have already had or are having the procedure with these devices to understand how they perform over time.

By collecting information from many patients, the study aims to confirm that these devices are safe and effective at repairing the leaky valve. They want to see if using these devices helps people feel better, improves their symptoms, and generally makes their lives better. This information helps doctors understand the long-term benefits and any potential downsides, which is vital for future patient care.

Key takeaways

Checks how two heart valve repair devices work in real patients.
Aims to see if devices are safe and improve patient health.
Focuses on people with a leaky heart valve problem.
Requires follow-up visits to monitor progress.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To be part of this study, you would need to have a leaky heart valve (mitral regurgitation) and be considered suitable for a specific type of repair procedure by a team of heart specialists, often called a 'Heart Team.' You must also be able and willing to come to all your follow-up appointments and complete any necessary tests.

Crucially, you would need to understand the study and agree to take part by giving your written consent. This shows you're happy to be involved and understand what it means.

Some reasons why you might not be able to join include if your particular situation doesn't fit the current guidelines for using these devices, or if you need the procedure done immediately in an emergency. Also, if you are already in the intensive care unit (ICU) before your procedure, you wouldn't be able to participate.

Quick self-check

Have I been told by a heart specialist team that I need this specific heart valve repair?
Am I willing and able to attend all necessary follow-up appointments?
Can I understand the study information and give my written permission to take part?
Am I not needing an emergency heart valve repair right now?
Am I not currently in intensive care before my procedure?

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

What does participation involve?

If you take part in this study, you will have your leaky heart valve repaired using one of the Edwards PASCAL devices. After your procedure, you'll need to attend scheduled follow-up visits with your doctor. These visits are important so doctors can check how you're recovering, how your heart valve is doing, and if your symptoms have improved. You may have various health checks and tests during these visits to see how the device is working and how you're generally feeling. The study will track your health over time, but the exact total duration and number of visits are not specified, you'd usually discuss this with your doctor before starting.

Potential risks and benefits

Taking part in this study means you would receive treatment for your leaky heart valve, which could improve your symptoms and quality of life. As with any medical procedure, there are potential risks, such as bleeding, infection, or issues related to the device itself. Your medical team will explain all known risks specific to the procedure. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (37)

Medizinische Universität Wien/AKH Wien
Vienna, Austria· Active not recruiting
Universitäts-Herzzentrum Freiburg Campus Bad Krozingen
Bad Krozingen, Germany· Recruiting
Universität Tuebingen
Tübingen, Germany· Recruiting
Uniklinikum Ulm
Ulm, Germany· Active not recruiting
Uniklinikum Erlangen
Erlangen, Germany· Recruiting
Medizinische Klinik I- Campus Grosshadern
München, Germany· Recruiting
Immanuel Klinikum Bernau
Bernau bei Berlin, Germany· Active not recruiting
Universitätsklinikum Giessen UKGM
Giessen, Germany· Recruiting
Universitaeres Herzzentrum Goettingen
Göttingen, Germany· Active not recruiting
Westdeutsches Herzzentrum / Uniklinik Essen
Essen, Germany· Recruiting
Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen
Essen, Germany· Recruiting
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, Germany· Recruiting

+25 more sites — see the official record for the full list.

Common questions

What is 'mitral regurgitation'?

It's when a valve in your heart, called the mitral valve, doesn't close properly, causing blood to flow backward.

What do the Edwards PASCAL devices do?

They are special tools used to help fix the leaky mitral valve in your heart.

Is this a new treatment?

No, these devices are already in use. This study is checking how well they work and how safe they are in patients over time.

Will I have extra doctor's appointments?

Yes, you would need to attend follow-up visits so doctors can check on your health and the device.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and your regular medical care will not be affected.

How to find out more

TMTT Clinical Affairs

TMTT_Clinical@edwards.com +1 (949) 250 Official trial record

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