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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04665596
Other study ID # CW19-01RS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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