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

Cardiawave

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: Ultrasound treatment of Calcified aortic valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT03779620

CW19-01

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-man

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. This is a FIM study

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).

2. Patient is not eligible for TAVR/SAVR .

3. Age ≥18 years.

4. Subjects who are willing to provide a written informed consent prior to participating in the study.

5. Subjects who can comply with the study follow up or other study requirements.

6. Subject eligible according to Clinical Review Committee

Exclusion criteria

1. Subjects with any electrical device implanted.

2. Subjects with unstable arrhythmia not controlled by medical treatment.

3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.

4. Subjects with complex congenital heart disease.

5. Chest deformity.

6. Cardiogenic shock.

7. History of heart transplant.

8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.

9. Thrombus in heart.

10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*.

11. Subjects who are pregnant or nursing.

12. Subjects who are participating in another research study for which the primary endpoint has not been reached.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ultrasound treatment

Experimental group

Description:

Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement

Treatment:

Device: Ultrasound treatment of Calcified aortic valve