Status:
COMPLETED
VALVOSOFT® Pivotal Study
Lead Sponsor:
Cardiawave SA
Collaborating Sponsors:
QbD Clinical
Conditions:
Aortic Valve Calcification
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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
- Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
- Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
- Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and
- Age ≥18 years; and
- Subject willing to provide a written informed consent prior to participating in the study; and
- Subject who can comply with the study follow-up or other study requirements; and
- Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).
Exclusion
- Subject with severe aortic regurgitation; or
- Subject with unstable arrhythmia not controlled by medical treatment; or
- Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
- Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or
- Cardiogenic shock or other hemodynamic instability; or
- Left Ventricular Ejection Fraction ≤30%; or
- Subject with mean AVAI \<0,24 cm²/m2; or
- History of heart transplant; or
- Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or
- Cardiac imaging evidence of vegetation; or
- Acute myocardial infarction (MI) within one month prior to enrolment; or
- Valve depth not suitable for NIUT (depth \>125mm with respect to the Valvosoft imaging probe); or
- Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or
- Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or
- Subject who is participating in another research study for which the primary endpoint has not been reached; or
- Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or
- Current endocarditis; or
- 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
- Life expectancy \< 6 months due to non-cardiac co-morbid conditions; or
- Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or
- Subjects who do not have Social Security and who are under legal restraint; or
- Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05235568
Start Date
June 15 2022
End Date
July 24 2024
Last Update
August 20 2024
Active Locations (11)
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1
CHU Lille Insitut Coeur Poumon
Lille, France
2
Hopital Bichat Claude-Bernard
Paris, France
3
Hopital Europeen Georges Pompidou
Paris, France
4
CHU Reims Hopital Robert Debré
Reims, France