New heart valve repair without open surgery: could it help High-Risk patients?

NCT ID NCT06700239

Not yet recruiting Disease control Sponsor: Micro Interventional Devices Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the MIA-T system, which is inserted through a catheter to repair the tricuspid valve in people with severe leakage. The trial will enroll 600 patients who are too high-risk for traditional surgery. The goal is to see if the device safely improves symptoms, reduces hospitalizations, and lowers the risk of death.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: MIA-T device (a catheter-based implant to repair the tricuspid valve)
What this could lead to: If successful, this could offer a safer, less invasive option for people with severe tricuspid regurgitation who cannot have open-heart surgery, potentially reducing hospitalizations and improving survival.
What could go wrong: This is a large but early-stage pivotal trial; the device may not work as well as hoped, and risks include heart-related complications, kidney failure, or infection. Long-term benefits are not yet proven.

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.

tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SEVERE TRICUSPID VALVE REGURGITATION TRICUSPID REGURGITATION TRICUSPID REGURGITATION FUNCTIONAL

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Other studies related to the condition(s) this trial covers.