New Balloon-Expandable heart valve tested in just 8 patients

NCT ID NCT07082426

Ongoing Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

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.

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 cardiovascular disorder

As listed by the trial registrant

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

SYMPTOMATIC SEVERE AORTIC STENOSIS

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

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