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New device aims to prevent blocked arteries during repeat heart valve surgery

NCT ID NCT06211296

Disease control Sponsor: Pi-cardia 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called ShortCut that splits the leaflets of a failing artificial heart valve before placing a new valve inside it. The goal was to prevent the old leaflets from blocking the coronary arteries, which can cause a heart attack. Eight people at risk for this complication took part, and researchers measured how well the device split the leaflets and whether it caused death or stroke.

What this could mean

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

Active substance
ShortCut device (splits bioprosthetic aortic valve leaflets)
What this could lead to
If successful, this device could help prevent serious complications like heart attack or stroke during valve-in-valve procedures for people with failing artificial heart valves.
What could go wrong
This was a very small study (8 people) with no comparison group, so results may not apply widely. The device itself carries risks of death or stroke.

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

Jul 2024

Finished

May 2025

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: 1. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve. 2. Patient is at risk for TAVR-induced coronary artery ostium obstruction. 3. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure. Exclusion Criteria: 1. An excessive aortic valve leaflet Calcium morphology, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the ShortCut™ device, as determined by the CT measurements. 2. Carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure. 3. CVA or TIA ≤ 6 months prior to index procedure. 4. History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure. 5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance. 6. LVEF \< 30%. 7. Ongoing severe infection or sepsis. 8. Patient has renal insufficiency or is on chronic dialysis. 8\. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Bites and Stings coronary artery disorder

As listed by the trial registrant

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

Aortic stenosis Coronary; obstruction Valve-in-valve procedures

Contacts and locations

Locations

  • Columbia University Medical Center /NYPH

    New York, New York, 10032, United States

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • UPMC Pinnacle

    Wormleysburg, Pennsylvania, 17043, United States

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