NCT07520591Not yet recruiting
Valvosoft Outcomes Registry for Real-World Evidence
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
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 3 Apr 2026
- Start date
- 30 May 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Cardiawave SA
- Diseases
- Heart failure
- NCT number
- NCT07520591
What you commit to
- Study type: Observational
- Planned participants: 200
- From 30 May 2026 to the primary completion date, 30 Jun 2027
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marienkrankenhaus Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| University Hospital Schleswig-Holstein, Campus KIEL Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Bichat Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Rouen Hopital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.