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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.

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