Clinical trial NCT04665596: Valvosoft First-In-Human 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-Human
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: 2020-12-11
Enrollment: 10
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 calcific aortic 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-Human

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. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.This is a FIM study

Eligibility criteria: Inclusion Criteria:

* Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve.
* Patient is not eligible for TAVR/SAVR according to local Heart Team.
* 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.
* Patient is eligible for the Valvosoft procedure according to CRC.

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.
* Thrombus in heart.
* Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment\*.
* Subjects who are pregnant or nursing.
* Subjects who are participating in another research study for which the primary endpoint has not been reached.

Primary outcomes:
measure: Safety: Rate of procedure related mortality
timeFrame: Up to 30 days
measure: Device performance to modify valve structure as measured by echocardiography
timeFrame: Immediately after the procedure
measure: Device performance to modify valve structure as measured by echocardiography
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to two years
measure: Rate of stroke
timeFrame: Up to two years
measure: Change of severity of heart failure
timeFrame: At 1, 3,6,12 and 24 months
measure: Major Adverse Events
timeFrame: Up to 2 years
measure: Adverse events
timeFrame: Up to 2 years
measure: User Handeling
timeFrame: Immediately after the procedure
measure: Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient
timeFrame: At 1, 3, 6,1 2 and 24 months
measure: quality of life measured through Kansas City Cardiomyopathy Questionnaire
timeFrame: at 1, 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Belgrad
country: Serbia
facility: Clinical Centre of Serbia
Study officials:
affiliation: Hospital Georges Pompidou, Paris, France
name: Emmanuel Messas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trifunovic-Zamaklar D, Velinovic M, Kovacevic-Kostic N, Messas E. Systematic brain magnetic resonance imaging and safety evaluation of non-invasive ultrasound therapy for patients with severe symptomatic aortic valve stenosis. Eur Heart J Cardiovasc Imaging. 2023 Jun 21;24(7):e108-e109. doi: 10.1093/ehjci/jead089. No abstract available.
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.