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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 15, 2022

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

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Mortality
    • Time Frame: 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
    • Time Frame: Up to two years
    • Rate of stroke
  • Change of severity of heart failure
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardiawave SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emmanuel Messas, MD, Principal Investigator, Hospital Georges Pompidou, Paris, France
  • Overall Contact(s)
    • Dirk Pauwels, +32475845836, dirk.pauwels@cardiawave.com

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