Valvosoft Outcomes Registry for Real-World Evidence

Overview

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.

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