Can a tiny implant fix a leaky heart valve without open surgery?
NCT ID NCT04679714
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial is testing a new device called the PLAR Implant, which is designed to treat severe functional mitral regurgitation—a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. The implant is placed via a catheter through a vein in the leg, avoiding open-heart surgery. The study will enroll up to 10 patients at high surgical risk and will follow them for 5 years to assess safety, feasibility, and how well the device works.
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 (transcatheter mitral valve repair device)
- What this could lead to
- If successful, this device could offer a less invasive treatment option for people with severe functional mitral regurgitation who are at high risk for surgery.
- What could go wrong
- This is an early, small study (up to 10 patients) focused on safety and feasibility, so results may not be conclusive. Risks include procedural complications and the device may not effectively reduce regurgitation.
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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