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
Verified date | January 2024 |
Source | Cardiawave SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
Serbia | Clinical Centre of Serbia | Belgrad |
Lead Sponsor | Collaborator |
---|---|
Cardiawave SA |
Serbia,
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
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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