New heart valve device could spare seniors from Open-Heart surgery

NCT ID NCT06414265

Recruiting now Disease control Sponsor: InnovHeart Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the SATURN system, which is implanted through a tube in a blood vessel to replace a leaky mitral heart valve. It is for people aged 65 and older with severe symptoms who are not good candidates for open-heart surgery. The goal is to see if the device is safe, can be placed correctly, and reduces the leak to a mild level or less.

What this could mean

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

Active substance: SATURN Trans-Septal TMVR System (a device implanted through a catheter to replace the mitral valve)
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.
What could go wrong: This is a small, early feasibility study with only 30 participants. The device may not work as expected, and there are risks like bleeding, infection, or device-related complications.

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.

heart failure mitral valve insufficiency

As listed by the trial registrant

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

HEART FAILURE

Contacts and locations

Locations

Górnośląskie Centrum Medyczne
RECRUITING

Katowice, Poland
Instituto Clinico Humanitas
RECRUITING

Milan, Italy
Ospedale San Raffaele
RECRUITING

Milan, 20132, Italy
Royal Sussex County Hospital
RECRUITING

Brighton, United Kingdom
Tbilisi Heart Center
RECRUITING

Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic
RECRUITING

Tbilisi, Georgia
Vilnius University Hospital Santaros Klinikos
RECRUITING

Vilnius, Lithuania
Warsaw Medical University
RECRUITING

Warsaw, Poland

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