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 CAS.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Rate of MACE <20% (NIM 5%) at 30-days post-procedure Performance:
Improvement in clinical status assessed by means of a decrease in NHYA
functional class at 30 days post procedure
Secondary outcome
Safety: 1. Rate of MACE peri-procedural and at 3-, 6- and 12-months
post-procedure; 2. All-cause mortality at 30 days, 3-, 6- and 12-months
post-procedure; 3. Rate of stroke (disabling and non-disabling; ischemic and
hemorrhagic) at 30-days, 3-, 6- and 12-months post-procedure; 4. Rate of all
adverse events up to 12 months. Performance: 1. Change of 10% in of aortic
stenosis by means of aortic valve area (AVA) (assessed by the independent
echocardiographic Central Core Laboratory) at 30 days compared to baseline 2.
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; 3. Change in severity of aortic stenosis by
means of transvalvular pressure gradient (mean & peak) and other hemodynamic
parameters (EF, Vmax, LVOT-Cardiac Output, LVOT Cardiac Index, LVOT Mean & Peak
Gradient, LVOT Peak Velocity, LVOT Stroke Volume indexed) at 30-days, 6- and
12-months compared to baseline (assessed by the independent echocardiographic
Central Core Laboratory). Clinical assessment: 1. Change in clinical status
assessed by means of a decrease in NYHA functional class from baseline to 3-,
6- and 12-months; 2. Frequency of presyncope/syncope and angina at 30-days, 3-,
6- and 12-months; 3. Improvement of quality of life by means of EQ-5D and KCCQ
from baseline to 30-days, 6-, and 12-months; 4. Change in 6-minutes* walk test
from baseline to 30-days, 6- and 12-months.
Background summary
Calcific Aortic Stenosis (CAS) affects 2 13% of the population aged 65 and
over. It has become a major public health concern because of the ageing western
population (by 2030 one person in three will be over the age of 65 in Europe).
The mean survival rate is 2 3 years for patients diagnosed with severe
symptomatic CAS: about 1.3 million patients in Europe are affected at present.
The only medical response to CAS is currently invasive: Surgical Aortic Valve
Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR). The
morbidity associated with both procedures remains high: 2 5% of patients die
during surgery or after 30 days, 17% die within 1 year, 35% within 3 years.
These surgeries also cause numerous complications (strokes, infections and
infarctions). The cost to the community is ultimately extremely high: e.g.,
more than 100,000$ per patient in the United States. In Europe and in the US,
direct and indirect costs associated with aortic valve disease were over 50
billion$ in 2012.
Moreover, not all patients are eligible for open-heart surgery or TAVR or they
refuse surgery (about 10 to 15% of patients).
CARDIAWAVE has developed a new non-invasive, real-time image-guided,
therapeutic approach to treat patients suffering from Calcific Aortic Stenosis.
CARDIAWAVE*s Valvosoft device is a new Non-Invasive Ultrasound Therapy (NIIUT)
based on a disruptive technology involving delivering an extremely precise and
focused ultrasound beam to perform a reparative effect on the aortic valve
leaflets, softening the valve*s tissues, restoring leaflet mobility, and
therefore improving the overall clinical status related to the aortic valve
stenosis.
Study objective
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 CAS.
Study design
Prospective, Multicenter, Single-arm, Pivotal Study.
Study burden and risks
The potential risks and benefits of participating in the present clinical
investigation are explicitly described in the Patient Information Sheet and are
to be explained to each subject and/or his/her legal representative prior to
participating in the study.
The risks of the procedure encompass those related to sedation medication and
those specific to the treatment, including:
• Allergic reaction to the material of Valvosoft Applicator (silicone).
• Aortic valve damage (hematoma, infiltration, perforation).
• Aortic valve regurgitation.
• Aortic valve thrombosis.
• Arrhythmia.
• Conduction disturbance.
• Death.
• Embolism: gas, (calcific) valve material.
• Heart failure.
• Hemolysis.
• Myocardial infarction.
• Pain.
• Sensitive surrounding structures/tissues damage (e.g. aorta, atrioventricular
node, lungs, myocardium,
valves).
• Skin lesion, bruise or ribs fracture.
• Stroke.
• Injuries to User.
There may be other potential AEs that are unforeseen at this time. The
occurrence of the above listed potential AEs may lead to discontinuation of the
procedure or study withdrawal and/or need for an alternative treatment (SAVR,
TAVR, balloon angioplasty).
Since Valvosoft is an investigational device, risks are not entirely known, but
are not believed to be more serious than those related to above mentioned
therapies.
Any known risks for participation in this study have been minimized during the
development process of Valvosoft and will be minimized through center selection
and training, implementation of a DSMB, User training program and proctoring as
well as in the conduct and management of the study including a careful
selection of patients, compliance with the Protocol and investigational device
IFU.
The sponsor, Medical Expert, and coordinating Investigator have determined that
this clinical investigation is justified because the potential benefits
outweigh the potential risks.
Rue Jules Guesde 3-5
Levallois-Perret 92300
FR
Rue Jules Guesde 3-5
Levallois-Perret 92300
FR
Listed location countries
Age
Inclusion criteria
A subject must meet following criteria to be enrolled in the investigation:
1. Subject suffering from severe symptomatic calcific aortic valve stenosis; 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; 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
A subject must not meet any of the following criteria to be enrolled in the
investigation: 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
the 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). 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 <12
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. 21. Subjects who do not have
Social Security and who are under legal restraint 22. Subjects who cannot read
or write or are mentally not or partially capable of giving informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05235568 |
| CCMO | NL80372.000.22 |