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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665596
Recruitment Status : Active, not recruiting
First Posted : December 11, 2020
Last Update Posted : January 8, 2024
Sponsor:
Information provided by (Responsible Party):
Cardiawave SA

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Ultrasound 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 : December 23, 2019
Actual Primary Completion Date : June 15, 2022
Estimated Study Completion Date : May 15, 2024

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Arms and Interventions
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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 Name: Ultrasound treatment of calcific aortic valve


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Rate of procedure related mortality [ Time Frame: Up to 30 days ]
    Rate of procedure related mortality at 30 days

  2. Device performance to modify valve structure as measured by echocardiography [ Time Frame: Immediately after the procedure ]
    Ability to modify the Left Ventricular Ejection Fraction (%)

  3. 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 Outcome Measures :
  1. All-cause 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

  2. Rate of stroke [ Time Frame: Up to two years ]
    Rate of stroke

  3. 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)

  4. 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

  5. Adverse events [ Time Frame: Up to 2 years ]
    Rate of all Adverse Events

  6. User Handeling [ Time Frame: Immediately after the procedure ]
    User handling (questionnaire for operator + procedure duration

  7. Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient [ Time Frame: At 1, 3, 6,1 2 and 24 months ]
    Long term maintenance of improvement of AVA and PG

  8. quality of life measured through Kansas City Cardiomyopathy Questionnaire [ Time Frame: at 1, 3, 6, 12 and 24 months ]
    Improvement of quality of life by means of KCCQ


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665596


Locations
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Serbia
Clinical Centre of Serbia
Belgrad, Serbia, 11000
Sponsors and Collaborators
Cardiawave SA
Investigators
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Principal Investigator: Emmanuel Messas, MD Hospital Georges Pompidou, Paris, France
More Information
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Publications:

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Responsible Party: Cardiawave SA
ClinicalTrials.gov Identifier: NCT04665596    
Other Study ID Numbers: CW19-01RS
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: January 8, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardiawave SA:
symptomatic
aortic valve
stenosis
ultrasound
non-invasive
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction