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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-man
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. 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 of Calcified aortic valve | Device | Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Rate of procedure related mortality at 30 days | Rate of procedure related mortality at 30 days | 30 days post-procedure |
| Device performance to modify valve structure as measured by echocardiography | Ability to modify the Aortic Valve Area (mm2) | Immediately post-procedure |
| Device performance to modify valve structure as measured by echocardiography | Ability to modify the Pressure Gradient (mmHg) | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality and major adverse events (MAE's) | Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively. | Up to 24 months |
| Non-disabling stroke |
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Inclusion Criteria:
Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
Patient is not eligible for TAVR/SAVR .
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.
Subject eligible according to Clinical Review Committee
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Messas, MD | HGEP Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | 75015 | France | |||
| Amphia Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37972628 | Result | 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. | |
| 33486971 |
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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 calcified aortic valve stenosis
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Rate of stroke at 1,3,6, 12 and 24 months
| Up to 24 months |
| Improvement of clinical status | Improvement 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. | Up to 24 months |
| Number of all Adverse Events (AEs) | Rate of AE's reported at at 1, 3, 6, 12 and 24 months | Up to 24 months |
| User handeling of Valvosoft | User handling (questionnaire for operator + procedure duration) immediately post-procedure | Immediately post-procedure |
| Improvement of quality of life | Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months | upto 24 months |
| Long term maintenance of improvement of AVA and PG | Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months | upto 24 months |
| Breda |
| 4818CK |
| Netherlands |
| Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available. |
| D014694 |
| Ventricular Outflow Obstruction |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |