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

Shock waves for stiff heart valves: new balloon tested in First-in-Human trial

NCT ID NCT06952374

Symptom relief Sponsor: Prince of Wales Hospital, Shatin, Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing a new balloon device called SmartWave that uses shock waves to break up calcium in severely narrowed mitral valves. The study enrolls 10 adults with symptomatic mitral stenosis caused by mitral annular calcification or severely calcified rheumatic heart disease. The goal is to see if the device can safely improve valve opening without causing major complications, potentially offering a new option for people who are not good candidates for standard balloon valvuloplasty or open-heart surgery.

What this could mean

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

Active substance
SmartWave lithotripsy balloon, a device that uses shock waves to break up calcium in heart valves
What this could lead to
If it works, this could offer a less invasive way to treat severely calcified mitral valves, possibly avoiding open-heart surgery or making follow-up valve procedures safer.
What could go wrong
This is a first-in-human study with only 10 participants, so safety and effectiveness are still unknown. The device could fail to open the valve, cause complications, or not work for everyone.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 and * Able to give procedure and study consent and * Severe symptomatic mitral stenosis (MVA \<1.5cm\^2 derived by 3D planimetry or continuity equation or pressure half time) and * Presence of mitral annular calcification or * CRHD with severe leaflet calcification with Wilkins score \>8 Exclusion Criteria: * Baseline \> moderate MR * Intracardiac thrombus as visualized by TEE * Pregnant patients. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure. * Active infection with bacteremia * Current participation in another investigational drug or device study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Mitral annulus calcification are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

mitral valve stenosis rheumatic disease of mitral valve rheumatic heart disease

As listed by the trial registrant

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

Mitral annulus calcification Rheumatic heart disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Prince of Wales Hospital

    RECRUITING

    Shatin, New Territories, 999077, Hong Kong

More trials for these conditions

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