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Sound waves instead of surgery: new device aims to soften stiff heart valves

NCT ID NCT07520591

Disease control Sponsor: Cardiawave SA 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry will follow 200 people with severe aortic valve stenosis who receive a non-invasive ultrasound therapy called Valvosoft. The treatment uses focused sound waves to soften calcium buildup on the valve without surgery. Researchers will track safety and effectiveness for 12 months after the procedure.

What this could mean

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

Active substance
non-invasive ultrasound therapy (Valvosoft device)
What this could lead to
If successful, this could offer a non-surgical option for people with severe aortic stenosis who cannot have or refuse valve replacement surgery.
What could go wrong
This is an early post-market registry with no control group, so results may not prove the therapy works better than alternatives. Risks include potential heart complications from the procedure.

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.

Participants

About 200 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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.

Who is studied

Patients suffering from calcific severe symptomatic AS, according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease, in adult patients not recommended by the local Heart Team for immediate TAVR/SAVR or refusing such interventions

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. Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease. 2. Not recommended by the local heart team for immediate TAVR/SAVR, or refusing such an intervention. 3. Willing to provide a written informed consent prior to participating in this Registry. 4. Able to comply with the follow up schedule or other Study requirements. Exclusion Criteria: 1. Prosthetic aortic valve; 2. Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator; 3. Thoracic injured skin, presence of scar(s) and/or burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator; 4. Pregnant or breastfeeding Patient.

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Conditions

The condition(s) this trial relates to.

aortic valve calcification Aortic Valve Disease aortic valve disorder aortic valve stenosis Aortic Valve, Calcification of heart failure

As listed by the trial registrant

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

Aortic stenosis, severe Aortic valve calcification Aortic valve disease Heart failure Ultrasound therapy

How to take part

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

  1. The places running it

    6 sites in 3 countries. 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

  • CHU Rouen Hopital Charles Nicolle

    Rouen, France

  • Hopital Bichat

    Paris, France

  • Hopital Europeen Georges Pompidou

    Paris, France

  • Marienkrankenhaus

    Hamburg, Germany

  • RadboudUMC

    Nijmegen, Netherlands

  • University Hospital Schleswig Holstein Campus Kiel

    Kiel, Germany

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