Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis

Cardiawave

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Device: Ultrasound treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT04665596

CW19-01RS

Details and patient eligibility

About

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

Full 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

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.