Aortic Valve StenosisNCT04665596
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
A study testing Ultrasound treatment in people with Aortic Valve Stenosis, run by Cardiawave SA at 1 site in Serbia.
Trial summary
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Ultrasound treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSerbia
- Study dates
- 23 Dec 2019to 23 May 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
- Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve.
- Patient is not eligible for TAVR/SAVR according to local Heart Team.
- Age ≥18 years.
- Subjects who are willing to provide a written informed consent prior to participating in the study.
- Subjects who can comply with the study follow up or other study requirements.
- Patient is eligible for the Valvosoft procedure according to CRC.
Who cannot join
- Subjects with any electrical device implanted.
- Subjects with unstable arrhythmia not controlled by medical treatment.
- Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
- Subjects with complex congenital heart disease.
- Chest deformity.
- Cardiogenic shock.
Show all 12Show fewer
- History of heart transplant.
- Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.
- Thrombus in heart.
- Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*.
- Subjects who are pregnant or nursing.
- Subjects who are participating in another research study for which the primary endpoint has not been reached.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
Read the detailed description
CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy 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. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.This is a FIM study
- Conditions
- Aortic Valve Stenosis
- Being tested
- Ultrasound treatment
- Keywords
- symptomatic, aortic valve, stenosis, ultrasound, non-invasive
- Medical subject headings
- Aortic Valve Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound treatmentDevice
Also called Ultrasound treatment of calcific aortic valve
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound treatment | Experimental | Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement Receives: Device: Ultrasound treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Rate of procedure related mortality
Rate of procedure related mortality at 30 days
Measured: Up to 30 days
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Left Ventricular Ejection Fraction (%)
Measured: Immediately after the procedure
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Mean Pressure Gradient (mmHg)
Measured: Immediately after the procedure
Secondary outcomes (8)
All-cause mortality
Number of patients that die during the course of the study and if so, how long aftre the procedure
Measured: Up to two years
Rate of stroke
Rate of stroke
Measured: Up to two years
Change of severity of heart failure
Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest)
Measured: At 1, 3,6,12 and 24 months
Major Adverse Events
Rate of Major Adverse Events (MAE) and number of patients with one or more MAE during the course of the study, an MAE defined as: Disabling stroke, Myocardial infarction or any clinically significant changes in biomarkers (CK, Troponin I - T) that would indicate damage to the heart structure, or clinically significant conduction disturbances requiring pacemaker implantation or persistent arrhythmias
Measured: Up to 2 years
Adverse events
Rate of all Adverse Events
Measured: Up to 2 years
User Handeling
User handling (questionnaire for operator + procedure duration
Measured: Immediately after the procedure
Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient
Long term maintenance of improvement of AVA and PG
Measured: At 1, 3, 6,1 2 and 24 months
quality of life measured through Kansas City Cardiomyopathy Questionnaire
Improvement of quality of life by means of KCCQ
Measured: at 1, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start23 Dec 2019
- Primary completion15 Jun 2022
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ultrasound treatment of calcific aortic stenosis
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiawave SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Messas, MD, Principal investigator, Hospital Georges Pompidou, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665596
- Sponsor's protocol ID
- CW19-01RS
- Status last verified
- Aug 2024
- First submitted
- 23 Nov 2020
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trifunovic-Zamaklar D, Velinovic M, Kovacevic-Kostic N, Messas E. Systematic brain magnetic resonance imaging and safety evaluation of non-invasive ultrasound therapy for patients with severe symptomatic aortic valve stenosis. Eur Heart J Cardiovasc Imaging. 2023 Jun 21;24(7):e108-e109. doi: 10.1093/ehjci/jead089. No abstract available.
PubMed 37158997Messas E, Ijsselmuiden A, Trifunovic-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzic D, Milicevic V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. 2023 Dec 16;402(10419):2317-2325. doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.
PubMed 37972628
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, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
- ClinicalTrials.gov ID
- NCT04665596
- Acronym / sponsor ID
- CW19-01RS
- Conditions
- Aortic Valve Stenosis
- Keywords
- symptomatic, aortic valve, stenosis, ultrasound, non-invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cardiawave SAIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 11 Dec 2020 (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.
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
Detailed description
CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy 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. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.This is a FIM study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ultrasound treatment of calcific aortic stenosis
| Arm | Type | Receives |
|---|---|---|
| Ultrasound treatment | Experimental | Device: Ultrasound treatmentUltrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve.
- Patient is not eligible for TAVR/SAVR according to local Heart Team.
- Age ≥18 years.
- Subjects who are willing to provide a written informed consent prior to participating in the study.
- Subjects who can comply with the study follow up or other study requirements.
Key exclusion criteria (12 listed)
- Subjects with any electrical device implanted.
- Subjects with unstable arrhythmia not controlled by medical treatment.
- Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
- Subjects with complex congenital heart disease.
- Chest deformity.
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 |
|---|---|---|
| Ultrasound treatmentAlso: Ultrasound treatment of calcific aortic valveUltrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen | Device | Ultrasound treatment |
Primary outcome
Safety: Rate of procedure related mortality
Time frame: Up to 30 days
Rate of procedure related mortality at 30 days
Device performance to modify valve structure as measured by echocardiography
Time frame: Immediately after the procedure
Ability to modify the Left Ventricular Ejection Fraction (%)
Device performance to modify valve structure as measured by echocardiography
Time frame: Immediately after the procedure
Ability to modify the Mean Pressure Gradient (mmHg)
8 secondary outcomes
All-cause mortality
Time frame: Up to two years
Rate of stroke
Time frame: Up to two years
Change of severity of heart failure
Time frame: At 1, 3,6,12 and 24 months
Major Adverse Events
Time frame: Up to 2 years
Adverse events
Time frame: Up to 2 years
User Handeling
Time frame: Immediately after the procedure
Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient
Time frame: At 1, 3, 6,1 2 and 24 months
quality of life measured through Kansas City Cardiomyopathy Questionnaire
Time frame: at 1, 3, 6, 12 and 24 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.
- Background: PubMed 37158997Trifunovic-Zamaklar D, Velinovic M, Kovacevic-Kostic N, Messas E. Systematic brain magnetic resonance imaging and safety evaluation of non-invasive ultrasound therapy for patients with severe symptomatic aortic valve stenosis. Eur Heart J Cardiovasc Imaging. 2023 Jun 21;24(7):e108-e109. doi: 10.1093/ehjci/jead089. No abstract available.
- Background: PubMed 37972628Messas E, Ijsselmuiden A, Trifunovic-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzic D, Milicevic V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. 2023 Dec 16;402(10419):2317-2325. doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.
- Individual participant dataSharing planned: No
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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.
Emmanuel Messas, MD principal investigator
Hospital Georges Pompidou, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound treatment in people with Aortic Valve Stenosis, run by Cardiawave SA at 1 site in Serbia.
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 6 inclusion and 12 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 1 site in Serbia. 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: Rate of procedure related mortality (time frame: Up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665596, which also lists 2 linked publications.
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.