A tiny implant might fix a leaky heart valve without cutting open the chest
NCT ID NCT04679662
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This early feasibility study tests a new device called the PLAR Implant, designed to treat severe degenerative mitral regurgitation—a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. The implant is delivered through a vein in the leg and guided to the heart, aiming to tighten the valve's support ring. The study will enroll up to 10 patients at high surgical risk and will follow them for five years to see if the procedure is safe and can reduce the severity of the leak.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- PLAR Implant and Delivery System (a device for transcatheter mitral valve repair)
- What this could lead to
- If successful, this could offer a less invasive treatment option for people with severe degenerative mitral regurgitation who are at high risk for open-heart surgery.
- What could go wrong
- This is a very early, small study (up to 10 patients) focused on safety and feasibility, not proof of effectiveness. The procedure carries risks such as bleeding, infection, or device-related complications, and results may not apply to a broader population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 05403-900, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart valve showdown: which fix works best for seniors?
- New device aims to fix leaky heart valves without stopping the heart
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- New heart valve fix device takes on market leader in major trial
- New heart valve implant offers hope for patients too sick for surgery