Brief Title
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
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
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
Study Type
Interventional
Primary Outcome
Safety: Rate of procedure related mortality
Secondary Outcome
Mortality
Condition
Aortic Valve Stenosis
Intervention
Ultrasound treatment
Study Arms / Comparison Groups
Ultrasound treatment
Description: Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
10
Start Date
December 23, 2019
Completion Date
February 15, 2023
Primary Completion Date
February 15, 2021
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Emmanuel Messas, MD, +33686300519, [email protected]
Location Countries
Serbia
Location Countries
Serbia
Administrative Informations
NCT ID
NCT04665596
Organization ID
CW-1901RS
Responsible Party
Sponsor
Study Sponsor
Cardiawave SA
Study Sponsor
Emmanuel Messas, MD, Principal Investigator, Hospital Georges Pompidou, Paris, France
Verification Date
December 2020