VALVOSOFT® Pivotal Study
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Valvosoft Treatment with VALVOSOFT device |
Device: VALVOSFT intervention
Treatment of the calcific aorta valve by non-invasive ultrasound therapy
|
Outcome Measures
Primary Outcome Measures
- Safety endpoint [at 30 days post-procedure]
Rate of MACE < 25%
- Performance endpoint [at 30 days post-procedure]
Improvement in clinical status assessed by means of a decrease in NHYA functional class
Secondary Outcome Measures
- 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 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
- 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
- NYHA improvement [3-, 6- and 12-months]
Change in clinical status assessed by means of a decrease in NYHA functional class
- Change in 6 minutes walk test [30 days, 6- and 12 months]
Change in 6-minutes' walk test
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
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Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
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Subject who refuses TAVR/SAVR, documented by local HEART Team; and
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Age ≥18 years; and
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Subject willing to provide a written informed consent prior to participating in the study; and
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Subject who can comply with the study follow-up or other study requirements; and
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Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).
Exclusion Criteria:
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Subject with severe aortic regurgitation; or
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Subject with unstable arrhythmia not controlled by medical treatment; or
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Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
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Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or
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Cardiogenic shock or other hemodynamic instability; or
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Left Ventricular Ejection Fraction ≤30%; or
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Subject with mean AVAI <0,24 cm²/m2; or
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History of heart transplant; or
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Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or
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Cardiac imaging evidence of vegetation; or
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Acute myocardial infarction (MI) within one month prior to enrolment; or
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Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging probe); or
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Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or
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Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or
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Subject who is participating in another research study for which the primary endpoint has not been reached; or
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Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or
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Current endocarditis; or
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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
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Life expectancy < 6 months due to non-cardiac co-morbid conditions; or
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Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or
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Subjects who do not have Social Security and who are under legal restraint; or
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Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Lille Insitut Coeur Poumon | Lille | France | ||
| 2 | Hopital Bichat Claude-Bernard | Paris | France | ||
| 3 | Hopital Europeen Georges Pompidou | Paris | France | ||
| 4 | CHU Rouen Hopital Charles Nicole | Rouen | France | ||
| 5 | Amphia Hospital | Breda | Netherlands |
Sponsors and Collaborators
- Cardiawave SA
- Trium Clinical Consulting
Investigators
- Principal Investigator: Christian Spaulding, MD, PhD, HEGP, Paris, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CW21-02