Aortic Valve CalcificationNCT05235568
VALVOSOFT® Pivotal Study
A study testing VALVOSFT intervention in people with Aortic Valve Calcification and Aortic Valve Stenosis, run by Cardiawave SA at 11 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Calcification, Aortic Valve Stenosis
- What is being tested?
- VALVOSFT intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 15 Jun 2022to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
France6 sites
CHU Lille Insitut Coeur Poumon
Lille
Hopital Bichat Claude-Bernard
Paris
Hopital Europeen Georges Pompidou
Paris
CHU Reims Hopital Robert Debré
Reims
CHU Rouen Hopital Charles Nicole
Rouen
Clinique Pasteur
Toulouse, 31076
Netherlands3 sites
OLVG
Amsterdam, 1091 AC
Amphia Hospital
Breda
Radboudumc
Nijmegen, 6525 AG
About this 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)
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
- Conditions
- Aortic Valve Calcification, Aortic Valve Stenosis
- Being tested
- VALVOSFT intervention
- Keywords
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve, Stenosis, Ultrasound, non invasive
- Medical subject headings
- Aortic Valve, Calcification of, Aortic Valve Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VALVOSFT interventionDevice
Treatment of the calcific aorta valve by non-invasive ultrasound therapy
| Study group | Role | What they receive |
|---|---|---|
| Valvosoft | Other | Treatment with VALVOSOFT device Receives: Device: VALVOSFT intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint
Rate of MACE < 25%
Measured: at 30 days post-procedure
Performance endpoint
Improvement in clinical status assessed by means of a decrease in NHYA functional class
Measured: at 30 days post-procedure
Secondary outcomes (9)
Rate of MACE
Rate of major adverse and cerebral events
Measured: peri-procedureal, and at 3-, 6- and 12 months post procedure
All cause mortality
All cause mortality
Measured: 30 days, 3-, 6- and 12-months post procedure
Rate of Stroke
Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)
Measured: 30 days, 3-, 6- and 12-months post procedure;
AVA change at 30 days
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
Measured: 30 days post procedure
AVA change in severity
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
Measured: at 6- and 12 months
NYHA improvement
Change in clinical status assessed by means of a decrease in NYHA functional class
Measured: 3-, 6- and 12-months
Change in 6 minutes walk test
Change in 6-minutes' walk test
Measured: 30 days, 6- and 12 months
Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire
Measured: 30 days, 6-, and 12-months
Improvement of quality of life by EQ-5D
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.
Measured: 30 days, 6-, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start15 Jun 2022
- Primary completion17 Aug 2023
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiawave SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QbD Clinical
- Responsible party
- Sponsor
- Investigators
- Christian Spaulding, MD, PhD, Principal investigator, HEGP, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235568
- Sponsor's protocol ID
- CW21-02
- Status last verified
- Aug 2024
- First submitted
- 20 Jan 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05235568
- Acronym / sponsor ID
- CW21-02
- Conditions
- Aortic Valve Calcification, Aortic Valve Stenosis
- Keywords
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve, Stenosis, Ultrasound, non invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cardiawave SAIndustry (pharma, biotech, devices)
- Collaborators
- QbD Clinical
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valvosoft | Other | Device: VALVOSFT interventionTreatment with VALVOSOFT device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VALVOSFT interventionTreatment of the calcific aorta valve by non-invasive ultrasound therapy | Device | Valvosoft |
Primary outcome
Safety endpoint
Time frame: at 30 days post-procedure
Rate of MACE < 25%
Performance endpoint
Time frame: at 30 days post-procedure
Improvement in clinical status assessed by means of a decrease in NHYA functional class
9 secondary outcomes
Rate of MACE
Time frame: peri-procedureal, and at 3-, 6- and 12 months post procedure
All cause mortality
Time frame: 30 days, 3-, 6- and 12-months post procedure
Rate of Stroke
Time frame: 30 days, 3-, 6- and 12-months post procedure;
AVA change at 30 days
Time frame: 30 days post procedure
AVA change in severity
Time frame: at 6- and 12 months
NYHA improvement
Time frame: 3-, 6- and 12-months
Change in 6 minutes walk test
Time frame: 30 days, 6- and 12 months
Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 30 days, 6-, and 12-months
Improvement of quality of life by EQ-5D
Time frame: 30 days, 6-, and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Calcification
RecruitingPhase 2
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Not yet recruitingObservational study
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
AORTIC VALVE DISEASES, Calcification; Heart
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Active, not recruitingPhase 3
Colchicine and Inflammation in Aortic Stenosis
Aortic Valve Disease, Aortic Valve Stenosis
RecruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Spaulding, MD, PhD principal investigator
HEGP, Paris, France
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VALVOSFT intervention in people with Aortic Valve Calcification and Aortic Valve Stenosis, run by Cardiawave SA at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint (time frame: at 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.