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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound treatment | Experimental | Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound treatment | Device | Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Rate of procedure related mortality | Rate of procedure related mortality at 30 days | Up to 30 days |
| Device performance to modify valve structure as measured by echocardiography | Ability to modify the Left Ventricular Ejection Fraction (%) | Immediately after the procedure |
| Device performance to modify valve structure as measured by echocardiography | Ability to modify the Mean Pressure Gradient (mmHg) | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of stroke | Rate of stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Messas, MD | Hospital Georges Pompidou, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Centre of Serbia | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37158997 | Background | 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. | |
| 37972628 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Ultrasound treatment of calcific aortic stenosis
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|
| Up to two years |
| 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 |
| 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 |
| Adverse events | Rate of all Adverse Events | Up to 2 years |
| User Handeling | User handling (questionnaire for operator + procedure duration | Immediately after the procedure |
| 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 |
| 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 |
| 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. |
| D014694 |
| Ventricular Outflow Obstruction |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |