New Balloon-Expandable heart valve tested in just 8 patients

NCT ID NCT07082426

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

Summary

This early study is testing a new balloon-expandable heart valve device (TAVI) in 8 people with severe aortic stenosis who are at increased surgical risk. The goal is to see if the device can be safely delivered and perform as intended. Because this is a first-in-human study with very few participants, the results are preliminary and may not apply to a wider population.

What this could mean

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

Active substance

balloon-expandable TAVI valve device

What this could lead to

If successful, this could lead to a new option for replacing a narrowed heart valve without open-heart surgery.

What could go wrong

This is a very early, first-in-human study with only 8 people. The device may not work as intended or could cause complications like valve leakage or heart damage.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiovascular disorder

As listed by the trial registrant

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

Contacts and locations

Locations

  • Israeli - Georgian Medical Research Clinic Healthycore

    Tbilisi, 0112, Georgia

  • Republican Centre of Emergency Medicine

    Tashkent, Toshknt, 100107, Uzbekistan

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, 0159, Georgia