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

Primary Purpose

Aortic Valve Stenosis

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Ultrasound treatment of Calcified aortic valve

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
-

Sites / Locations

Hôpital Européen Georges Pompidou
Amphia Hospital

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 at 30 days

Rate of procedure related mortality at 30 days

Device performance to modify valve structure as measured by echocardiography

Ability to modify the Aortic Valve Area (mm2)

Device performance to modify valve structure as measured by echocardiography

Ability to modify the Pressure Gradient (mmHg)

Secondary Outcome Measures

All-cause mortality and major adverse events (MAE's)

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

Rate of stroke at 1,3,6, 12 and 24 months

Improvement of clinical status

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 all Adverse Events (AEs)

Rate of AE's reported at at 1, 3, 6, 12 and 24 months

User handeling of Valvosoft

User handling (questionnaire for operator + procedure duration) immediately post-procedure

Improvement of quality of life

Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months

Long term maintenance of improvement of AVA and PG

Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months

Full Information

NCT ID

NCT03779620

First Posted

November 12, 2018

Last Updated

March 27, 2023

Sponsor

Cardiawave SA

1. Study Identification

Unique Protocol Identification Number

NCT03779620

Brief Title

Valvosoft First-In-Man 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-Man

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 13, 2019 (Actual)

Primary Completion Date

January 15, 2022 (Actual)

Study Completion Date

December 1, 2023 (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

Studies a U.S. FDA-regulated Device Product

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-man

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

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 calcified aortic valve stenosis

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (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 of Calcified aortic valve

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety: Rate of procedure related mortality at 30 days

Description

Rate of procedure related mortality at 30 days

Time Frame

30 days post-procedure

Title

Device performance to modify valve structure as measured by echocardiography

Description

Ability to modify the Aortic Valve Area (mm2)

Time Frame

Immediately post-procedure

Title

Device performance to modify valve structure as measured by echocardiography

Description

Ability to modify the Pressure Gradient (mmHg)

Time Frame

Immediately post-procedure

Secondary Outcome Measure Information:

Title

All-cause mortality and major adverse events (MAE's)

Description

Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively.

Time Frame

Up to 24 months

Title

Non-disabling stroke

Description

Rate of stroke at 1,3,6, 12 and 24 months

Time Frame

Up to 24 months

Title

Improvement of clinical status

Description

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.

Time Frame

Up to 24 months

Title

Number of all Adverse Events (AEs)

Description

Rate of AE's reported at at 1, 3, 6, 12 and 24 months

Time Frame

Up to 24 months

Title

User handeling of Valvosoft

Description

User handling (questionnaire for operator + procedure duration) immediately post-procedure

Time Frame

Immediately post-procedure

Title

Improvement of quality of life

Description

Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months

Time Frame

upto 24 months

Title

Long term maintenance of improvement of AVA and PG

Description

Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months

Time Frame

upto 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emmanuel Messas, MD

Organizational Affiliation

HGEP Paris, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Européen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Amphia Hospital

City

Breda

ZIP/Postal Code

4818CK

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33486971

Citation

Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available.

Results Reference

derived

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

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