Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart valve scoring device trial halted after just one patient

NCT ID NCT05052684

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 device called Leaflex™ Performer, which is threaded through a blood vessel to the heart to score and loosen calcium buildup on stiff aortic valves. It was designed for people with severe aortic stenosis who cannot have standard valve surgery or replacement. However, the trial was terminated early after enrolling only one person, so we have very little information about how well it works or its safety.

What this could mean

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

Active substance
Leaflex™ Performer (a catheter device that scores calcification in heart valve leaflets)
What this could lead to
If it worked, this device could offer a less invasive treatment option for people with severe aortic stenosis who cannot have standard valve replacement.
What could go wrong
The trial was terminated early with only 1 participant, so results are very limited. The device may not be safe or effective, and risks include stroke, valve damage, or worsening heart function.

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

1 person

The number who actually took part.

Started

Oct 2022

Finished

Nov 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 to 100 years

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: * Patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement. * Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent. Exclusion Criteria: * Severe aortic regurgitation. * Anatomic contraindications. * Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure. * Aortic balloon valvuloplasty ≤ 3 months prior to index procedure. * Stroke ≤ 12 months prior to index procedure. * History of a myocardial infarction ≤ 6 weeks prior to index procedure. * Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy. * Hemodynamic instability. * Hypertrophic cardiomyopathy with obstruction. * Left ventricle ejection fraction \<30%. * Ongoing severe infection, including endocarditis, or sepsis. * Life expectancy ≤ 12 months.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve stenosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Aortic valve stenosis

Contacts and locations

Locations

  • Instituto do Coração FMUSP Centro de Pesquisa

    São Paulo, 05403-000, Brazil

More trials for these conditions

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