CompletedNot Applicable

Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis

France, Netherlands30 participantsStarted 2019-03-13

Plain-language summary

This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
✓. Patient is not eligible for TAVR/SAVR .
✓. Age ≥18 years.
✓. Subjects who are willing to provide a written informed consent prior to participating in the study.
✓. Subjects who can comply with the study follow up or other study requirements.
✓. Subject eligible according to Clinical Review Committee

Exclusion criteria

✕. Subjects with any electrical device implanted.
✕. Subjects with unstable arrhythmia not controlled by medical treatment.
✕. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
✕. Subjects with complex congenital heart disease.
✕. Chest deformity.
✕. Cardiogenic shock.
✕. History of heart transplant.
✕. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.

What they're measuring

Safety: Rate of procedure related mortality at 30 days

Timeframe: 30 days post-procedure

Device performance to modify valve structure as measured by echocardiography

Timeframe: Immediately post-procedure

Device performance to modify valve structure as measured by echocardiography

Timeframe: Immediately post-procedure

Trial details

NCT IDNCT03779620

SponsorCardiawave SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-15

View on ClinicalTrials.gov More Aortic Valve Stenosis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
✓. Patient is not eligible for TAVR/SAVR .
✓. Age ≥18 years.
✓. Subjects who are willing to provide a written informed consent prior to participating in the study.
✓. Subjects who can comply with the study follow up or other study requirements.
✓. Subject eligible according to Clinical Review Committee

Exclusion criteria

✕. Subjects with any electrical device implanted.
✕. Subjects with unstable arrhythmia not controlled by medical treatment.
✕. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
✕. Subjects with complex congenital heart disease.
✕. Chest deformity.
✕. Cardiogenic shock.
✕. History of heart transplant.
✕. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.

What they're measuring

Safety: Rate of procedure related mortality at 30 days

Timeframe: 30 days post-procedure

Device performance to modify valve structure as measured by echocardiography

Timeframe: Immediately post-procedure

Device performance to modify valve structure as measured by echocardiography

Timeframe: Immediately post-procedure