CompletedNot Applicable

VALVOSOFT® Pivotal Study

France60 participantsStarted 2022-06-15

Plain-language summary

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

Who can participate

Age range18 Years

SexALL

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

Inclusion criteria

✓. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
✓. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
✓. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and
✓. Age ≥18 years; and
✓. Subject willing to provide a written informed consent prior to participating in the study; and
✓. Subject who can comply with the study follow-up or other study requirements; and
✓. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).

Exclusion criteria

✕. Subject with severe aortic regurgitation; or
✕. Subject with unstable arrhythmia not controlled by medical treatment; or
✕. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
✕. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or
✕. Cardiogenic shock or other hemodynamic instability; or
✕. Left Ventricular Ejection Fraction ≤30%; or
✕. Subject with mean AVAI \<0,24 cm²/m2; or
✕. History of heart transplant; or

What they're measuring

Safety endpoint

Timeframe: at 30 days post-procedure

Performance endpoint

Timeframe: at 30 days post-procedure

Trial details

NCT IDNCT05235568

SponsorCardiawave SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-17

View on ClinicalTrials.gov More Aortic Valve Calcification trials