Clinical trial NCT05235568: VALVOSOFT® Pivotal Study
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Calcification
Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
Aortic Valve Calcification
Aortic Valve
Stenosis
Ultrasound
non invasive
Lead sponsor: Cardiawave SA
Sponsor class: INDUSTRY
Collaborators: name: QbD Clinical
First posted: 2022-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Safety endpoint
timeFrame: at 30 days post-procedure
measure: Performance endpoint
timeFrame: at 30 days post-procedure
Secondary outcomes:
measure: Rate of MACE
timeFrame: peri-procedureal, and at 3-, 6- and 12 months post procedure
measure: All cause mortality
timeFrame: 30 days, 3-, 6- and 12-months post procedure
measure: Rate of Stroke
timeFrame: 30 days, 3-, 6- and 12-months post procedure;
measure: AVA change at 30 days
timeFrame: 30 days post procedure
measure: AVA change in severity
timeFrame: at 6- and 12 months
measure: NYHA improvement
timeFrame: 3-, 6- and 12-months
measure: Change in 6 minutes walk test
timeFrame: 30 days, 6- and 12 months
measure: Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 days, 6-, and 12-months
measure: Improvement of quality of life by EQ-5D
timeFrame: 30 days, 6-, and 12-months
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille Insitut Coeur Poumon
city: Paris
country: France
facility: Hopital Bichat Claude-Bernard
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Reims
country: France
facility: CHU Reims Hopital Robert Debré
city: Rouen
country: France
facility: CHU Rouen Hopital Charles Nicole
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Nauheim
country: Germany
facility: Kerckhoff-klinik
city: Hamburg
country: Germany
facility: Marienkrankenhaus
city: Amsterdam
country: Netherlands
facility: OLVG
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: HEGP, Paris, France
name: Christian Spaulding, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: