Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
Primary Purpose
Aortic Valve Stenosis
Status
Active
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Ultrasound treatment
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring symptomatic, aortic valve, stenosis, ultrasound, non-invasive
Eligibility 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.
Sites / Locations
- Clinical Centre of Serbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound treatment
Arm Description
Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement
Outcomes
Primary Outcome Measures
Safety: Rate of procedure related mortality
Rate of procedure related mortality at 30 days
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Left Ventricular Ejection Fraction (%)
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Mean Pressure Gradient (mmHg)
Secondary Outcome Measures
All-cause mortality
Number of patients that die during the course of the study and if so, how long aftre the procedure
Rate of stroke
Rate of stroke
Change of severity of heart failure
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
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
Adverse events
Rate of all Adverse Events
User Handeling
User handling (questionnaire for operator + procedure duration
Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient
Long term maintenance of improvement of AVA and PG
quality of life measured through Kansas City Cardiomyopathy Questionnaire
Improvement of quality of life by means of KCCQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04665596
Brief Title
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiawave SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
symptomatic, aortic valve, stenosis, ultrasound, non-invasive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Ultrasound treatment of calcific aortic stenosis
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound treatment
Arm Type
Experimental
Arm Description
Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement
Intervention Type
Device
Intervention Name(s)
Ultrasound treatment
Other Intervention Name(s)
Ultrasound treatment of calcific aortic valve
Intervention Description
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen
Primary Outcome Measure Information:
Title
Safety: Rate of procedure related mortality
Description
Rate of procedure related mortality at 30 days
Time Frame
Up to 30 days
Title
Device performance to modify valve structure as measured by echocardiography
Description
Ability to modify the Left Ventricular Ejection Fraction (%)
Time Frame
Immediately after the procedure
Title
Device performance to modify valve structure as measured by echocardiography
Description
Ability to modify the Mean Pressure Gradient (mmHg)
Time Frame
Immediately after the procedure
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Number of patients that die during the course of the study and if so, how long aftre the procedure
Time Frame
Up to two years
Title
Rate of stroke
Description
Rate of stroke
Time Frame
Up to two years
Title
Change of severity of heart failure
Description
Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest)
Time Frame
At 1, 3,6,12 and 24 months
Title
Major Adverse Events
Description
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
Time Frame
Up to 2 years
Title
Adverse events
Description
Rate of all Adverse Events
Time Frame
Up to 2 years
Title
User Handeling
Description
User handling (questionnaire for operator + procedure duration
Time Frame
Immediately after the procedure
Title
Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient
Description
Long term maintenance of improvement of AVA and PG
Time Frame
At 1, 3, 6,1 2 and 24 months
Title
quality of life measured through Kansas City Cardiomyopathy Questionnaire
Description
Improvement of quality of life by means of KCCQ
Time Frame
at 1, 3, 6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Messas, MD
Organizational Affiliation
Hospital Georges Pompidou, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Centre of Serbia
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
No
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Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
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