Aortic Valve DiseaseVALOR-PMCFNCT07520591
Valvosoft Outcomes Registry for Real-World Evidence
An observational study of Aortic Valve Disease and Aortic Stenosis, Severe, run by Cardiawave SA at 6 sites in 3 countries.
Trial summary
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification
- What is being tested?
- Valvosoft Treatment
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 30 May 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients suffering from calcific severe symptomatic AS, according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease, in adult patients not recommended by the local Heart Team for immediate TAVR/SAVR or refusing such interventions
Who may be able to join
- Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease.
- Not recommended by the local heart team for immediate TAVR/SAVR, or refusing such an intervention.
- Willing to provide a written informed consent prior to participating in this Registry.
- Able to comply with the follow up schedule or other Study requirements.
Who cannot join
- Prosthetic aortic valve;
- Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator;
- Thoracic injured skin, presence of scar(s) and/or burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator;
- Pregnant or breastfeeding Patient.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
France3 sites
Hopital Bichat
Paris
Hopital Europeen Georges Pompidou
Paris
CHU Rouen Hopital Charles Nicolle
Rouen
Germany2 sites
Marienkrankenhaus
Hamburg
University Hospital Schleswig Holstein Campus Kiel
Kiel
About this study
Official title: Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS).
Valvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue.
This registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.
Read the detailed description
Severe symptomatic calcific aortic stenosis is associated with high morbidity and mortality, and some patients are not eligible for or decline standard valve replacement therapies (TAVR/SAVR).
Valvosoft® is an ultrasound image-guided, non-invasive therapy designed to mechanically soften calcified aortic valve leaflets using focused ultrasound energy without thermal damage.
The VALOR-PMCF registry is a prospective, multicenter study conducted to confirm the safety, clinical performance, and benefit-risk profile of Valvosoft® in real-world practice following CE marking.
Participants will be followed for up to 12 months to assess safety events, clinical status (NYHA), quality of life (KCCQ), and echocardiographic parameters, including aortic valve area and transvalvular gradients.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy, Heart Failure
- Being tested
- Valvosoft Treatment
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valvosoft TreatmentDevice
Also called NIUT
non-invasive ultrasound therapy for the treatment of severe symptomatic calcific AS
| Study group | Role | What they receive |
|---|---|---|
| observational group | patients suffering from severe AS, not recommended for immediate AVR by local HEART Team or refusing an AVR and are treated with Valvosoft Receives: Device: Valvosoft Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MACE
Rate of MACE defined as a composite endpoint including all-cause mortality, myocardial infarction, stroke, myocardial infarction and rehospitalization for heart failure, up to 30-days post procedure(s)
Measured: at 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiawave SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- T!Write
- Responsible party
- Sponsor
- Investigators
- Won-Keun Kim, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520591
- Sponsor's protocol ID
- CW26-02
- Acronym
- VALOR-PMCF
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy
- ClinicalTrials.gov ID
- NCT07520591
- Acronym / sponsor ID
- VALOR-PMCF / CW26-02
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy, Heart Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardiawave SAIndustry (pharma, biotech, devices)
- Collaborators
- T!Write
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Apr 2026 (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 VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS).
Valvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue.
This registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.
Detailed description
Severe symptomatic calcific aortic stenosis is associated with high morbidity and mortality, and some patients are not eligible for or decline standard valve replacement therapies (TAVR/SAVR).
Valvosoft® is an ultrasound image-guided, non-invasive therapy designed to mechanically soften calcified aortic valve leaflets using focused ultrasound energy without thermal damage.
The VALOR-PMCF registry is a prospective, multicenter study conducted to confirm the safety, clinical performance, and benefit-risk profile of Valvosoft® in real-world practice following CE marking.
Participants will be followed for up to 12 months to assess safety events, clinical status (NYHA), quality of life (KCCQ), and echocardiographic parameters, including aortic valve area and transvalvular gradients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | Device: Valvosoft Treatmentpatients suffering from severe AS, not recommended for immediate AVR by local HEART Team or refusing an AVR and are treated with Valvosoft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from calcific severe symptomatic AS, according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease, in adult patients not recommended by the local Heart Team for immediate TAVR/SAVR or refusing such interventions
Key inclusion criteria (4 listed)
- Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease.
- Not recommended by the local heart team for immediate TAVR/SAVR, or refusing such an intervention.
- Willing to provide a written informed consent prior to participating in this Registry.
- Able to comply with the follow up schedule or other Study requirements.
Key exclusion criteria (4 listed)
- Prosthetic aortic valve;
- Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator;
- Thoracic injured skin, presence of scar(s) and/or burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator;
- Pregnant or breastfeeding Patient.
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 |
|---|---|---|
| Valvosoft TreatmentAlso: NIUTnon-invasive ultrasound therapy for the treatment of severe symptomatic calcific AS | Device | observational group |
Primary outcome
Rate of MACE
Time frame: at 30 days post procedure
Rate of MACE defined as a composite endpoint including all-cause mortality, myocardial infarction, stroke, myocardial infarction and rehospitalization for heart failure, up to 30-days post procedure(s)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
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Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
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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.
Won-Keun Kim principal investigator
University Hospital Schleswig-Holstein
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Aortic Stenosis, Severe, run by Cardiawave SA at 6 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dirk Pauwels (+33 (0)1 55 26 82 19, dirk.pauwels@cardiawave.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MACE (time frame: at 30 days post procedure). 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 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.