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

Sponsor

Cardiawave SA (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03779620

Collaborator

(none)

Enrollment

Locations

Arm

56.6

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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-man

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: Ultrasound treatment of Calcified aortic valve	N/A

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. This is a FIM study

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Ultrasound treatment of calcified aortic valve stenosisUltrasound treatment of calcified aortic valve stenosis

Masking:

None (Open Label)

Primary Purpose:

Treatment

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-Man

Actual Study Start Date :

Mar 13, 2019

Actual Primary Completion Date :

Jan 15, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound treatment Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement	Device: 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

Arm

Intervention/Treatment

Experimental: Ultrasound treatment

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

Device: 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

Outcome Measures

Primary Outcome Measures

Safety: Rate of procedure related mortality at 30 days [30 days post-procedure]
Rate of procedure related mortality at 30 days
Device performance to modify valve structure as measured by echocardiography [Immediately post-procedure]
Ability to modify the Aortic Valve Area (mm2)
Device performance to modify valve structure as measured by echocardiography [Immediately post-procedure]
Ability to modify the Pressure Gradient (mmHg)

Secondary Outcome Measures

All-cause mortality and major adverse events (MAE's) [Up to 24 months]
Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively.
Non-disabling stroke [Up to 24 months]
Rate of stroke at 1,3,6, 12 and 24 months
Improvement of clinical status [Up to 24 months]
Improvement of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) at 1,3,6,12, and 24 months.
Number of Major Adverse Events (MAEs) [Up to 24 months]
Rate of MAE's at 1, 3, 6, 12 and 24 months post operatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
Patient is not eligible for TAVR/SAVR .
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.
Subject eligible according to Clinical Review Committee

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.