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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04665596
• Other study ID #: CW19-01RS
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: May 15, 2024

Study information

• Verified date: January 2024
• Source: Cardiawave SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 15, 2024
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Ultrasound treatment
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen

Locations

Country	Name	City	State
Serbia	Clinical Centre of Serbia	Belgrad

Sponsors (1)

Lead Sponsor	Collaborator
Cardiawave SA

Country where clinical trial is conducted

Serbia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Rate of procedure related mortality	Rate of procedure related mortality at 30 days	Up to 30 days
Primary	Device performance to modify valve structure as measured by echocardiography	Ability to modify the Left Ventricular Ejection Fraction (%)	Immediately after the procedure
Primary	Device performance to modify valve structure as measured by echocardiography	Ability to modify the Mean Pressure Gradient (mmHg)	Immediately after the procedure
Secondary	All-cause mortality	Number of patients that die during the course of the study and if so, how long aftre the procedure	Up to two years
Secondary	Rate of stroke	Rate of stroke	Up to two years
Secondary	Change of severity of heart failure	Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest)	At 1, 3,6,12 and 24 months
Secondary	Major Adverse Events	Rate of Major Adverse Events (MAE) and number of patients with one or more MAE during the course of the study, an MAE defined as: Disabling stroke, Myocardial infarction or any clinically significant changes in biomarkers (CK, Troponin I - T) that would indicate damage to the heart structure, or clinically significant conduction disturbances requiring pacemaker implantation or persistent arrhythmias	Up to 2 years
Secondary	Adverse events	Rate of all Adverse Events	Up to 2 years
Secondary	User Handeling	User handling (questionnaire for operator + procedure duration	Immediately after the procedure
Secondary	Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient	Long term maintenance of improvement of AVA and PG	At 1, 3, 6,1 2 and 24 months
Secondary	quality of life measured through Kansas City Cardiomyopathy Questionnaire	Improvement of quality of life by means of KCCQ	at 1, 3, 6, 12 and 24 months