Clinical trial NCT03779620: Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: symptomatic
aortic valve
stenosis
ultrasound
non-invasive
Lead sponsor: Cardiawave SA
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ultrasound treatment of calcified aortic valve stenosis
Primary purpose: TREATMENT

Brief 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

Detailed description: CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. This is a FIM study

Eligibility criteria: Inclusion Criteria:

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

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Exclusion Criteria:

1. Subjects with any electrical device implanted.
2. Subjects with unstable arrhythmia not controlled by medical treatment.
3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
4. Subjects with complex congenital heart disease.
5. Chest deformity.
6. Cardiogenic shock.
7. History of heart transplant.
8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.
9. Thrombus in heart.
10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment\*.
11. Subjects who are pregnant or nursing.
12. Subjects who are participating in another research study for which the primary endpoint has not been reached.

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Primary outcomes:
measure: Safety: Rate of procedure related mortality at 30 days
timeFrame: 30 days post-procedure
measure: Device performance to modify valve structure as measured by echocardiography
timeFrame: Immediately post-procedure
measure: Device performance to modify valve structure as measured by echocardiography
timeFrame: Immediately post-procedure
Secondary outcomes:
measure: All-cause mortality and major adverse events (MAE's)
timeFrame: Up to 24 months
measure: Non-disabling stroke
timeFrame: Up to 24 months
measure: Improvement of clinical status
timeFrame: Up to 24 months
measure: Number of all Adverse Events (AEs)
timeFrame: Up to 24 months
measure: User handeling of Valvosoft
timeFrame: Immediately post-procedure
measure: Improvement of quality of life
timeFrame: upto 24 months
measure: Long term maintenance of improvement of AVA and PG
timeFrame: upto 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Breda
country: Netherlands
facility: Amphia Hospital
Study officials:
affiliation: HGEP Paris, France
name: Emmanuel Messas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messas E, Ijsselmuiden A, Trifunovic-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzic D, Milicevic V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. 2023 Dec 16;402(10419):2317-2325. doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.
citation: Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available.