VALVOSOFT® Pivotal Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2024-07-24

Brief Summary

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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

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Detailed Description

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Conditions

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Aortic Valve Calcification Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Valvosoft

Treatment with VALVOSOFT device

Group Type OTHER

VALVOSFT intervention

Intervention Type DEVICE

Treatment of the calcific aorta valve by non-invasive ultrasound therapy

Interventions

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VALVOSFT intervention

Treatment of the calcific aorta valve by non-invasive ultrasound therapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No