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

Sponsor

Cardiawave SA (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04665596

Collaborator

(none)

Enrollment

Location

Arm

40.7

Anticipated Duration (Months)

0.2

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-Human

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: Ultrasound treatment	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. 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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Ultrasound treatment of calcific aortic stenosisUltrasound treatment of calcific aortic 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-Human

Actual Study Start Date :

Dec 23, 2019

Actual Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

May 15, 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 Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen Other Names: Ultrasound treatment of calcific aortic valve

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

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

Other Names:

Ultrasound treatment of calcific aortic valve

Outcome Measures

Primary Outcome Measures

Safety: Rate of procedure related mortality [Up to 30 days]
Rate of procedure related mortality at 30 days
Device performance to modify valve structure as measured by echocardiography [Immediately after the procedure]
Ability to modify the Aortic Valve Area (mm2)
Device performance to modify valve structure as measured by echocardiography [Immediately after the procedure]
Ability to modify the Left Ventricular Ejection Fraction (%)
Device performance to modify valve structure as measured by echocardiography [Immediately after the procedure]
Ability to modify the Mean Pressure Gradient (mmHg)

Secondary Outcome Measures

Mortality [Up to two years]
Number of patients that die during the course of the study and if so, how long aftre the procedure
Rate of stroke [Up to two years]
Rate of stroke
Change of severity of heart failure [At 1,3,6,12 and 24 months]
Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest)
Major Adverse Events [Up to 2 years]
Rate of Major Adverse Events (MAE) and number of patients with one or more MAE during the course of the study, an MAE defined as: Disabling stroke, Myocardial infarction or any clinically significant changes in biomarkers (CK, Troponin I - T) that would indicate damage to the heart structure, or clinically significant conduction disturbances requiring pacemaker implantation or persistent arrhythmias

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 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.