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New Balloon-Expandable heart valve tested in just 8 patients

NCT ID NCT07082426

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

8 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Increased surgical risk * Appropriate anatomy * At least 18 years of age * Willing to return for follow-up assessments Exclusion Criteria: * Pregnant or nursing subjects * Anatomic or comorbid conditions * Evidence of acute myocardial infarction * Inoperable/ineligible for surgery * Renal disease requiring chronic dialysis

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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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