New heart valve device tested in tiny early study

NCT ID NCT07116551

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 system from Abbott for people with severe, symptomatic aortic stenosis. The valve is delivered through a catheter, avoiding open-heart surgery. Only 11 participants are enrolled to check if the device is safe and works as intended.

What this could mean

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

Active substance: Abbott BE TAVI System (a balloon-expandable heart valve replacement device)
What this could lead to: If successful, this could lead to a new, less invasive option for replacing a narrowed heart valve, potentially improving survival and quality of life for people with severe aortic stenosis.
What could go wrong: This is a very early, small study with only 11 people, so results may not apply to everyone. The device could fail or cause complications like bleeding, stroke, or need for a permanent pacemaker.

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

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Clinique Pasteur Toulouse

Toulouse, Midpyre, 31076, France
Columbia University Medical Center/New York-Presbyterian

New York, New York, 10032, United States
Montefiore Medical Center - Moses Division

The Bronx, New York, 10461, United States
Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

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