Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT04665596
- Lead Sponsor
- Cardiawave SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:<br><br> - Subjects suffering from severe symptomatic aortic valve stenosis according to ESC<br> 2017 definition, including subjects with a bicuspid valve.<br><br> - Patient is not eligible for TAVR/SAVR according to local Heart Team.<br><br> - Age =18 years.<br><br> - Subjects who are willing to provide a written informed consent prior to<br> participating in the study.<br><br> - Subjects who can comply with the study follow up or other study requirements.<br><br> - Patient is eligible for the Valvosoft procedure according to CRC.<br><br>Exclusion Criteria:<br><br> - Subjects with any electrical device implanted.<br><br> - Subjects with unstable arrhythmia not controlled by medical treatment.<br><br> - Subjects with implanted mechanical valve in any position or bio prosthetic valve in<br> aortic position.<br><br> - Subjects with complex congenital heart disease.<br><br> - Chest deformity.<br><br> - Cardiogenic shock.<br><br> - History of heart transplant.<br><br> - Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral<br> valve procedure, tricuspid valve procedure) within one month after treatment.<br><br> - Thrombus in heart.<br><br> - Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within<br> one month prior to enrolment*.<br><br> - Subjects who are pregnant or nursing.<br><br> - Subjects who are participating in another research study for which the primary<br> endpoint has not been reached.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Rate of procedure related mortality;Device performance to modify valve structure as measured by echocardiography;Device performance to modify valve structure as measured by echocardiography
- Secondary Outcome Measures
Name Time Method All-cause mortality;Rate of stroke;Change of severity of heart failure;Major Adverse Events;Adverse events;User Handeling;Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient;quality of life measured through Kansas City Cardiomyopathy Questionnaire