New heart valve device aims to save lives without Open-Heart surgery

NCT ID NCT07278310

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the Siegel TAVR System to replace a narrowed heart valve in people with severe aortic stenosis. About 1,025 participants with symptoms will receive the device. Researchers will track deaths, strokes, and heart-related hospitalizations for one year to see if the device is safe and effective.

What this could mean

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

Active substance: Siegel TAVR Device (a replacement heart valve implanted via catheter)
What this could lead to: If successful, this could offer a safer, more effective option for replacing a narrowed heart valve without open-heart surgery.
What could go wrong: This is a large trial, but the device is new and may have unknown risks. Results will take time, and not all patients may benefit equally.

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.

aortic valve stenosis

As listed by the trial registrant

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

AORTIC STENOSIS SYMPTOMATIC SEVERE NATIVE AORTIC STENOSIS

Contacts and locations

Locations

Piedmont Heart Institute
RECRUITING

Atlanta, Georgia, 30309, United States

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