Mitral valve implant for heart failure with leaky mitral valve
Part of Heart & circulation clinical trials.
This trial tests whether a device called the Carillon Mitral Contour System can help people with heart failure caused by a mild-to-moderate leaky mitral valve. You’d be compared against a control group, and the goal is to improve heart failure symptoms and outcomes.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have heart failure symptoms from a leaky mitral valve that is mild (at least 1+).
- Your heart failure is in NYHA stages II, III, or IV (the common symptom categories your cardiologist uses).
- You can walk at least 100 meters but not more than 600 meters in six minutes.
- Your heart pumping strength (ejection fraction) is 50% or less, and your heart size measures fit the trial’s limits.
- You recently had high NT-proBNP (a heart-stress blood test) and/or were hospitalized for heart failure or needed stronger heart failure medicines in the past year.
- You must not have prior valve repair devices or certain valve problems, severe valve calcification, severe other valve disease (like severe aortic stenosis), or likely need heart surgery soon.
- You must be 18 or older, be able to get the device sized/placed as instructed, and agree to long-term follow-up visits (including possible randomization to control).
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This registry collects health information from adults who already have the Carillon device to treat a leaky mitral valve caused by dilated heart muscle. The goal is to better understand how the device performs in real-world care over time.
This trial tests a device placed during open heart surgery that tightens the leaking mitral valve to reduce blood flowing backward. It may help people whose valve leak is caused by heart muscle weakness and who are already having another heart surgery.
This trial tests a new device for people whose mitral valve leaks badly (grade 3+ or 4+) and who are not candidates for surgery. The device aims to fix the leak through a less invasive approach, and the study checks if it's safe and works well in daily life.
This trial tests a new device that is placed using a thin tube through a vein in the leg to repair a leaky mitral valve in people with heart failure. The goal is to see if it can reduce symptoms and improve quality of life beyond what usual medications can do.
This trial tests a new device called the SATURN system, which places a new mitral valve without open-heart surgery. It is for people aged 65 and older with severe mitral regurgitation who are at high risk for surgery.
This trial tests a new device called AMEND™ that is placed through a vein in the leg to repair a leaky mitral valve without open-heart surgery. It is for people with significant mitral regurgitation who are at high risk for surgery.
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