Aortic Valve Stenosis
Conditions
Keywords
symptomatic, aortic valve, stenosis, ultrasound, non-invasive
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
Interventions
DEVICEUltrasound treatment
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen
Sponsors
Cardiawave SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Ultrasound treatment of calcific aortic stenosis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Rate of procedure related mortality | Up to 30 days | Rate of procedure related mortality at 30 days |
| Device performance to modify valve structure as measured by echocardiography | Immediately after the procedure | Ability to modify the Left Ventricular Ejection Fraction (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of severity of heart failure | At 1, 3,6,12 and 24 months | Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) |
| Major Adverse Events | Up to 2 years | 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 |
| Adverse events | Up to 2 years | Rate of all Adverse Events |
| All-cause mortality | Up to two years | Number of patients that die during the course of the study and if so, how long aftre the procedure |
| Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient | At 1, 3, 6,1 2 and 24 months | Long term maintenance of improvement of AVA and PG |
| quality of life measured through Kansas City Cardiomyopathy Questionnaire | at 1, 3, 6, 12 and 24 months | Improvement of quality of life by means of KCCQ |
| User Handeling | Immediately after the procedure | User handling (questionnaire for operator + procedure duration |
| Rate of stroke | Up to two years | Rate of stroke |
Countries
Serbia
Outcome results
None listed