VALVOSOFT® Pivotal Study

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Aortic Valve Calcification
• Interventions: Device: VALVOSFT intervention

• Registration Number: NCT05235568
• Lead Sponsor: Cardiawave SA

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-11
• Study Start: 2022-06-15
• Primary Completion: 2023-08-17
• Study Completion: 2024-07-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valvosoft	VALVOSFT intervention	Treatment with VALVOSOFT device

Primary Outcome Measures

Name	Time	Method
Performance endpoint	at 30 days post-procedure	Improvement in clinical status assessed by means of a decrease in NHYA functional class
Safety endpoint	at 30 days post-procedure	Rate of MACE \< 25%

Secondary Outcome Measures

Name	Time	Method
Rate of MACE	peri-procedureal, and at 3-, 6- and 12 months post procedure	Rate of major adverse and cerebral events
All cause mortality	30 days, 3-, 6- and 12-months post procedure	All cause mortality
Rate of Stroke	30 days, 3-, 6- and 12-months post procedure;	Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)
AVA change in severity	at 6- and 12 months	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
Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)	30 days, 6-, and 12-months	Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire
Change in 6 minutes walk test	30 days, 6- and 12 months	Change in 6-minutes' walk test
AVA change at 30 days	30 days post procedure	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
NYHA improvement	3-, 6- and 12-months	Change in clinical status assessed by means of a decrease in NYHA functional class
Improvement of quality of life by EQ-5D	30 days, 6-, and 12-months	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.

Trial Locations

Locations (11)

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

OLVG; 🇳🇱 Amsterdam, Netherlands

CHU Lille Insitut Coeur Poumon; 🇫🇷 Lille, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Hopital Bichat Claude-Bernard; 🇫🇷 Paris, France

CHU Reims Hopital Robert Debré; 🇫🇷 Reims, France

CHU Rouen Hopital Charles Nicole; 🇫🇷 Rouen, France

Kerckhoff-klinik; 🇩🇪 Bad Nauheim, Germany

Marienkrankenhaus; 🇩🇪 Hamburg, Germany

Amphia Hospital; 🇳🇱 Breda, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands