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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2023-09-27

Brief Summary

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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

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Detailed Description

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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

Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Ultrasound treatment of calcified aortic valve stenosis

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound treatment

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

Group Type EXPERIMENTAL

Ultrasound treatment of Calcified aortic valve

Intervention Type DEVICE

Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement

Interventions

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Ultrasound treatment of Calcified aortic valve

Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement

Intervention Type DEVICE

Eligibility Criteria

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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

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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.

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No