Aortic Valve StenosisNCT03779620
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
A study testing Ultrasound treatment of Calcified aortic valve in people with Aortic Valve Stenosis, run by Cardiawave SA at 2 sites in 2 countries.
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-man 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 of Calcified aortic valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Mar 2019to 27 Sep 2023
- 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 (including subjects with a bicuspid valve).
- Patient is not eligible for TAVR/SAVR .
- 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.
- Subject eligible according to Clinical Review Committee
- -
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 13Show 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
2 sites in 2 countries.
2 sites in 2 countries
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-Man
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-man
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. This is a FIM study
- Conditions
- Aortic Valve Stenosis
- Being tested
- Ultrasound treatment of Calcified aortic valve
- 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 treatment of Calcified aortic valveDevice
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement
| 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 of Calcified aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Rate of procedure related mortality at 30 days
Rate of procedure related mortality at 30 days
Measured: 30 days post-procedure
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Aortic Valve Area (mm2)
Measured: Immediately post-procedure
Device performance to modify valve structure as measured by echocardiography
Ability to modify the Pressure Gradient (mmHg)
Measured: Immediately post-procedure
Secondary outcomes (7)
All-cause mortality and major adverse events (MAE's)
Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively.
Measured: Up to 24 months
Non-disabling stroke
Rate of stroke at 1,3,6, 12 and 24 months
Measured: Up to 24 months
Improvement of clinical status
Improvement of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) at 1,3,6,12, and 24 months.
Measured: Up to 24 months
Number of all Adverse Events (AEs)
Rate of AE's reported at at 1, 3, 6, 12 and 24 months
Measured: Up to 24 months
User handeling of Valvosoft
User handling (questionnaire for operator + procedure duration) immediately post-procedure
Measured: Immediately post-procedure
Improvement of quality of life
Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months
Measured: upto 24 months
Long term maintenance of improvement of AVA and PG
Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months
Measured: upto 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start13 Mar 2019
- Primary completion15 Jan 2022
- Study completion27 Sep 2023
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 calcified aortic valve stenosis
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiawave SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Messas, MD, Principal investigator, HGEP Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779620
- Sponsor's protocol ID
- CW19-01
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2018
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Messas 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 37972628Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available.
PubMed 33486971
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 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-Man
- ClinicalTrials.gov ID
- NCT03779620
- Acronym / sponsor ID
- CW19-01
- Conditions
- Aortic Valve Stenosis
- Keywords
- symptomatic, aortic valve, stenosis, ultrasound, non-invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardiawave SAIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 19 Dec 2018 (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-man
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. 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 calcified aortic valve stenosis
| Arm | Type | Receives |
|---|---|---|
| Ultrasound treatment | Experimental | Device: Ultrasound treatment of Calcified aortic valveUltrasound 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 (7 listed)
- Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
- Patient is not eligible for TAVR/SAVR .
- 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 (13 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 treatment of Calcified aortic valveUltrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement | Device | Ultrasound treatment |
Primary outcome
Safety: Rate of procedure related mortality at 30 days
Time frame: 30 days post-procedure
Rate of procedure related mortality at 30 days
Device performance to modify valve structure as measured by echocardiography
Time frame: Immediately post-procedure
Ability to modify the Aortic Valve Area (mm2)
Device performance to modify valve structure as measured by echocardiography
Time frame: Immediately post-procedure
Ability to modify the Pressure Gradient (mmHg)
7 secondary outcomes
All-cause mortality and major adverse events (MAE's)
Time frame: Up to 24 months
Non-disabling stroke
Time frame: Up to 24 months
Improvement of clinical status
Time frame: Up to 24 months
Number of all Adverse Events (AEs)
Time frame: Up to 24 months
User handeling of Valvosoft
Time frame: Immediately post-procedure
Improvement of quality of life
Time frame: upto 24 months
Long term maintenance of improvement of AVA and PG
Time frame: upto 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 15 Oct 2024.
- Results publication: 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.
- Derived from this study: PubMed 33486971Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available.
- 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
HGEP Paris, France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound treatment of Calcified aortic valve in people with Aortic Valve Stenosis, run by Cardiawave SA at 2 sites in 2 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 13 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Netherlands. 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 at 30 days (time frame: 30 days post-procedure). 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 NCT03779620, 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 15 Oct 2024.