New Catheter-Based valve replacement offers hope for High-Risk heart patients

NCT ID NCT07130994

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

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This early study tests a new device called the SATURN TS TMVR System, which is implanted through a catheter to replace the mitral valve in people with severe mitral regurgitation. Up to 15 patients who are too high-risk for open-heart surgery will be enrolled. The goal is to see if the device can be safely implanted and reduce the backward flow of blood in the heart.

What this could mean

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

Active substance: SATURN TS TMVR System (a device implanted via 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 very early feasibility study with only 15 participants, so results may not apply widely. The procedure carries risks like stroke, heart damage, or need for reintervention.

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 disorder mitral valve insufficiency

As listed by the trial registrant

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

HEART DISEASE MITRAL REGURGITATION

Contacts and locations

Locations

Cedars-Sinai Medical Center
NOT_YET_RECRUITING

Los Angeles, California, 90048, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Los Robles Regional Medical Center
RECRUITING

Thousand Oaks, California, 91360, United States
Oregon Health & Science University
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
UC Davis Health
NOT_YET_RECRUITING

Sacramento, California, 95817, United States

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