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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779620
• Other study ID #: CW19-01
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: September 27, 2023

Study information

• Verified date: January 2024
• Source: Cardiawave SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 27, 2023
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).

2. Patient is not eligible for TAVR/SAVR .

3. Age =18 years.

4. Subjects who are willing to provide a written informed consent prior to participating in the study.

5. Subjects who can comply with the study follow up or other study requirements.

6. Subject eligible according to Clinical Review Committee

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Exclusion Criteria:

1. Subjects with any electrical device implanted.

2. Subjects with unstable arrhythmia not controlled by medical treatment.

3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.

4. Subjects with complex congenital heart disease.

5. Chest deformity.

6. Cardiogenic shock.

7. History of heart transplant.

8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.

9. Thrombus in heart.

10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*.

11. Subjects who are pregnant or nursing.

12. Subjects who are participating in another research study for which the primary endpoint has not been reached.

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Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris
Netherlands	Amphia Hospital	Breda

Sponsors (1)

Lead Sponsor	Collaborator
Cardiawave SA

Countries where clinical trial is conducted

France,  Netherlands, 

References & Publications (1)

Messas E, Ijsselmuiden A, Trifunovic-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzic D, Milicevic V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. 2023 Dec 16;402(10419):2317-2325. doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Rate of procedure related mortality at 30 days	Rate of procedure related mortality at 30 days	30 days post-procedure
Primary	Device performance to modify valve structure as measured by echocardiography	Ability to modify the Aortic Valve Area (mm2)	Immediately post-procedure
Primary	Device performance to modify valve structure as measured by echocardiography	Ability to modify the Pressure Gradient (mmHg)	Immediately post-procedure
Secondary	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.	Up to 24 months
Secondary	Non-disabling stroke	Rate of stroke at 1,3,6, 12 and 24 months	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	Number of all Adverse Events (AEs)	Rate of AE's reported at at 1, 3, 6, 12 and 24 months	Up to 24 months
Secondary	User handeling of Valvosoft	User handling (questionnaire for operator + procedure duration) immediately post-procedure	Immediately post-procedure
Secondary	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	upto 24 months
Secondary	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	upto 24 months