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Heart valve fix gets a High-Tech upgrade: Self-Centering catheter tested in humans

NCT ID NCT06412354

Symptom relief Sponsor: Vivheart s.r.l. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called VIVHEART EasyCross™ in 20 people undergoing transcatheter aortic valve replacement (TAVR). The device uses a basket-like tip to center itself in the artery, making it easier and quicker to guide a wire through the heart valve. The goal was to see if it is safe and can reduce procedure time.

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

20 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 2024

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: * Age: ≥18 years old * Candidate to TAVR of a native valve, recrossing and balloon postdilation of a prosthetic aortic valve, or a valve-in-valve aortic valve replacement. * Willingness to undergo follow-up visits. * Ability to understand scope, content and risks of the study, and provide informed consent to participation. Exclusion Criteria: * Contraindications for endovascular procedures * Pregnancy or breastfeeding females at screening and at time of investigational procedure * Hemodynamically unstable or other clinical conditions increasing the risk of transcatheter valve procedure failure * Needing emergent procedure * Allergies to components of the device * Allergies to drugs or contrast material that may be used during the investigational procedure and all the TAVR procedure * Participation in another clinical trial

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Transcatheter aortic valve replacement (TAVR)

Contacts and locations

Locations

  • San Raffaele Scientific Institute

    Milan, 20132, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.