VALVOSOFT® Pivotal Study

Aortic Valve Stenosis Clinical Trial

Official title:

Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05235568
• Other study ID #: CW21-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: August 15, 2024

Study information

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

Clinical Trial Summary

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 15, 2024
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and

2. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or

3. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and

4. Age =18 years; and

5. Subject willing to provide a written informed consent prior to participating in the study; and

6. Subject who can comply with the study follow-up or other study requirements; and

7. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).

Exclusion Criteria:

1. Subject with severe aortic regurgitation; or

2. Subject with unstable arrhythmia not controlled by medical treatment; or

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

4. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or

5. Cardiogenic shock or other hemodynamic instability; or

6. Left Ventricular Ejection Fraction =30%; or

7. Subject with mean AVAI <0,24 cm²/m2; or

8. History of heart transplant; or

9. Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or

10. Cardiac imaging evidence of vegetation; or

11. Acute myocardial infarction (MI) within one month prior to enrolment; or

12. Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging probe); or

13. Stroke or transient ischemic attack (TIA) =1 month prior to enrollment; or

14. Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or

15. Subject who is participating in another research study for which the primary endpoint has not been reached; or

16. Balloon aortic valvuloplasty (BAV) =3 months prior to enrollment; or

17. Current endocarditis; or

18. Leukopenia (WBC <4000 cell/µL), anemia (Hgb <8 g/dL), thrombocytopenia (platelet count <15.000 cell/µL), or history of coagulopathy or hypercoagulable state; or

19. Life expectancy < 6 months due to non-cardiac co-morbid conditions; or

20. Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or

21. Subjects who do not have Social Security and who are under legal restraint; or

22. Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.

Related Conditions & MeSH terms

• Aortic Valve Calcification
• Aortic Valve Stenosis
• Calcinosis
• Constriction, Pathologic

Intervention

Device:
• VALVOSFT intervention
Treatment of the calcific aorta valve by non-invasive ultrasound therapy

Locations

Country	Name	City	State
France	CHU Lille Insitut Coeur Poumon	Lille
France	Hopital Bichat Claude-Bernard	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	CHU Reims Hopital Robert Debré	Reims
France	CHU Rouen Hopital Charles Nicole	Rouen
France	Clinique Pasteur	Toulouse
Germany	Kerckhoff-klinik	Bad Nauheim
Germany	Marienkrankenhaus	Hamburg
Netherlands	OLVG	Amsterdam
Netherlands	Amphia Hospital	Breda
Netherlands	Radboudumc	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Cardiawave SA	QbD Clinical

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoint	Rate of MACE < 25%	at 30 days post-procedure
Primary	Performance endpoint	Improvement in clinical status assessed by means of a decrease in NHYA functional class	at 30 days post-procedure
Secondary	Rate of MACE	Rate of major adverse and cerebral events	peri-procedureal, and at 3-, 6- and 12 months post procedure
Secondary	All cause mortality	All cause mortality	30 days, 3-, 6- and 12-months post procedure
Secondary	Rate of Stroke	Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)	30 days, 3-, 6- and 12-months post procedure;
Secondary	AVA change at 30 days	Change of 10% in of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) 30 days post procedure compared to baseline	30 days post procedure
Secondary	AVA change in severity	Change in severity of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) at 6- and 12 months compared to baseline	at 6- and 12 months
Secondary	NYHA improvement	Change in clinical status assessed by means of a decrease in NYHA functional class	3-, 6- and 12-months
Secondary	Change in 6 minutes walk test	Change in 6-minutes' walk test	30 days, 6- and 12 months
Secondary	Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)	Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire	30 days, 6-, and 12-months
Secondary	Improvement of quality of life by EQ-5D	Improvement of quality of life by means of EQ-5D. The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	30 days, 6-, and 12-months