Follow-up of people with severe aortic stenosis treated with Valvosoft ultrasound therapy
Follows people with severe aortic stenosis treated with Valvosoft ultrasound for 12 months.
Plain-language title generated from the registry record
Registry title: Valvosoft Outcomes Registry for Real-World Evidence
Key facts
- Where
- Nijmegen, NetherlandsSee the site
Where in Netherlands
- RadboudumcNijmegen, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cardiawave SA
- Trial code
- NCT07520591
- Record updated
- 14 April 2026
- Original description
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).Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.