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.
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.
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.
Cardiawave SA
Lead sponsor
T!Write
Collaborator