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Sound waves instead of surgery? new device trial for stiff heart valves

NCT ID NCT06650839

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 was designed to test the safety of a device called Valvosoft, which uses ultrasound waves from outside the body to treat moderate aortic valve stenosis. The goal was to see if it could improve valve movement without major complications. However, the trial was withdrawn before any patients were enrolled, so no results are available.

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 treatment option for moderate aortic valve stenosis, potentially reducing the need for invasive procedures.
What could go wrong
This trial was withdrawn before enrolling any participants, so no data exist. The approach is still early-stage, and safety and effectiveness are unproven.

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.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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.

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. Aortic Valve Area (AVA) ≥1.0 cm2 ≤ 1.5 cm2 and either mean aortic Pressure Gradient (mPG) of \>25 - \< 40 mmHg or maximum velocity (Vmax) ≥3 ≤4 m/sec in normal flow conditions; or 2. Normal-flow, low-gradient aortic stenosis (AS) with preserved ejection fraction (mean aortic Pressure Gradient (mPG) \<40 mmHg, Aortic Valve Area (AVA) ≥0.8 ≤1.0 cm2, Left Ventricular Ejection Fraction (LVEF) ≥50%, Stroke Volume Index (SVi) \>35 mL/m2); 3. Age ≥18 years; Exclusion Criteria: 1. mPG ≥40 mmHg; or 2. Severe aortic valve stenosis or other severe valve diseases; or 3. Subject with severe aortic regurgitation; or 4. Subjects with implanted mechanical or bioprosthetic valve in aortic position, or mechanical valve in any other positions; or 5. Heart failure with a NYHA 3 or 4; or 6. Cardiogenic shock or other hemodynamic instability; or 7. LVEF ≤50%; or 8. History of heart transplant; or 9. Subject with a significant kidney disease (eGFR ≤30 mL/min/1.73 m2) or subject is on dialysis; or 10. Subject with uncontrolled hypertension defined as systolic Blood Pressure (BP) ≥160 mmHg and/or a diastolic BP ≥100 mmHg (mean of 3 measurements for both assessments); or 11. Cardiac imaging evidence of vegetation; or 12. Current endocarditis; or 13 Subject has a documented history of cardiac amyloidosis; or 14\. Acute Myocardial Infarction (MI) ≤1 month prior to enrolment; or 15. Stroke or Transient Ischemic attack (TIA) ≤1 month prior to enrollment; or 16. Balloon Aortic Valvuloplasty (BAV) ≤3 months prior to enrollment; or 17. Leukopenia (WBC \<4000 cell/μL), anemia (Hgb \< 8 g/dL), thrombocytopenia (platelet count \<50.000 cell/μL), or history of coagulopathy or hypercoagulable state.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis follicular lymphoma

As listed by the trial registrant

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

Moderate aortic valve stenosis

Contacts and locations

Locations

  • University Clinical Centre Serbia

    Belgrade, 11000, Serbia

More trials for these conditions

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