Active not recruitingNAINTERVENTIONAL

Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

This research trial is designed to see if a new device, called the AccuCinch® Ventricular Repair System, can help people living with severe heart failure. This condition means your heart muscle is weakened and struggles to pump blood effectively, often becoming enlarged. The study is looking at how safe the AccuCinch device is and how well it works to improve heart function and reduce symptoms like breathlessness. It focuses on patients whose heart failure is due to a stretched and weakened heart muscle, whether or not they also have a leaky heart valve. The goal is to evaluate if this new approach can offer relief to those who are still struggling despite taking their usual medications.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ancora Heart, Inc.

Enrolment target

132

Start

15 Jan 2019

Estimated completion

01 Dec 2027

Heart Failure Cardiomyopathies

What is this study about?

Heart failure means your heart isn't pumping blood around your body as well as it should. This can make you feel very tired and breathless. Sometimes, the main pumping chamber of your heart, called the left ventricle, becomes stretched and enlarged. This makes it even harder for your heart to work properly. This study is looking at a new device called the AccuCinch® Ventricular Repair System that aims to help improve this.

The AccuCinch system is designed to make the enlarged left ventricle smaller and reshape it. The idea is that if the heart chamber is a better size and shape, it can pump blood more efficiently. This could potentially reduce your symptoms and improve your quality of life. The doctors want to find out how safe the device is and how well it performs in real-world patients.

This study is for adults who have severe heart failure because their heart muscle has become stretched and weakened. This can be due to different conditions, including 'dilated cardiomyopathy,' which means the heart muscle is weak and enlarged. Some patients in the study might also have a leaky heart valve (called functional mitral regurgitation), while others might not. All participants will have been on standard heart failure medicines for some time, but are still experiencing bothersome symptoms.

Key takeaways

This study evaluates a new device for severe heart failure.
The AccuCinch® aims to improve heart pumping by reshaping the heart's main chamber.
It's for adults with an enlarged, weakened heart, even if on medication.
Potential benefits include improved symptoms, but risks are involved.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have heart failure because your heart muscle is enlarged and weakened. Your heart's pumping ability (ejection fraction) must be between 20% and 40%, and your symptoms should be moderate to severe, despite taking your regular heart failure medications for at least three months.

If you also have a leaky heart valve, the leak must be at least 'moderate.' If you don't have a leaky valve, the main pumping chamber of your heart must be noticeably enlarged (at least 55mm in diameter). For those with a leaky valve, doctors will also need to decide you're at a high risk for standard heart valve surgery, which means the AccuCinch might be a better option.

There are also reasons you might not be able to join. For example, if your life expectancy is less than a year for non-heart reasons, or if you have very severe heart failure that requires immediate intensive care. Certain other heart conditions like 'hypertrophic cardiomyopathy' (where the heart muscle is too thick) would also prevent you from joining, as this study is specifically for dilated hearts.

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.

Are you 18 years of age or older?
Do you have heart failure because your heart muscle is stretched and weak?
Are you currently taking heart failure medications, but still experiencing symptoms?
Has your doctor told you your heart's pumping ability (ejection fraction) is between 20% and 40%?
If you have a leaky heart valve, is it considered at least 'moderate'?
If you don't have a leaky valve, has your doctor said your left ventricle is noticeably enlarged (at least 55mm)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the AccuCinch® Ventricular Repair System. This involves a medical procedure where the device is carefully placed. After the procedure, you would have several follow-up visits with the study team. These visits will involve various tests, such as heart scans and general health checks, to monitor your recovery and see how the device is working. You will continue to take your prescribed medications as directed by your doctors. The study aims to follow participants over a period of time to understand the long-term safety and effectiveness of the device. The exact duration of your participation, including the number and frequency of visits, would be fully explained by the study team.

Potential risks and benefits

Like any medical procedure, there are potential benefits and risks to consider. A potential benefit of taking part is that the AccuCinch device might improve your heart's ability to pump blood, reduce your heart failure symptoms, and improve your quality of life, especially if other treatments haven't fully helped. However, there are also risks associated with the procedure itself, such as bleeding, infection, or other complications, and the device might not work for everyone. The long-term effects of this new device are still being studied. You will be closely monitored, and your medical team will explain all the known risks before you make any decisions. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

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

Republican Scientific and Practical Centre of Cardiology
Verified postcode
Minsk, Belarus
Onze Lieve Vrouwziekenhuis
Verified postcode
Aalst, Belgium
AZ Sint-Jan Brugge
Verified postcode
Bruges, Belgium
Na Homolce Hospital
Verified postcode
Prague, Czechia
Pessac (CHU Bordeaux)
Verified postcode
Pessac, France
Hôpital Cardio-Vasculaire Louis Pradel
Verified postcode
Bron, France
Hôpital de La Timone
Verified postcode
Marseille, France
Paris Hôpital de la Pitié-Salpêtrière
Verified postcode
Paris, France
Hôpital Civil de Strasbourg
Verified postcode
Strasbourg, France
Clinique Pasteur
Verified postcode
Toulouse, France
IRCCS Policlinico San Donato
Verified postcode
Milan, Italy
Maria Cecilia Hospital
Verified postcode
Cotignola, Italy

Common questions

What is heart failure?

Heart failure means your heart isn't pumping enough blood around your body. It doesn't mean your heart has stopped, but that it's not working as efficiently as it should. This often leads to symptoms like tiredness and breathlessness.

What is the AccuCinch® device?

It's a new medical device being tested in this study. It's designed to help reshape and support the main pumping chamber of an enlarged heart, aiming to improve its function.

Will I have to stop my current medications?

No, you will likely continue to take your regular heart failure medications. In fact, you must have been on stable doses of these medicines for a while before joining the study.

Is this device surgery?

The AccuCinch device is put in during a medical procedure, but it's not the same as traditional open-heart surgery. However, the study will only accept patients who are healthy enough to undergo a potential conversion to open surgery if needed for safety reasons during the procedure.

Can I choose not to participate?

Yes, taking part in any clinical trial is always completely voluntary. You can decide not to join, or you can withdraw at any time, without it affecting your medical care.