Valvosoft Outcomes Registry for Real-World Evidence
NCT: NCT07520591 · NOT_YET_RECRUITING
Brief 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 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.
Frequently Asked Questions
What is Valvosoft Outcomes Registry for Real-World Evidence?
Valvosoft Outcomes Registry for Real-World Evidence is a clinical trial registered under NCT07520591. Current status: NOT_YET_RECRUITING.
What is the status of NCT07520591?
The current status of NCT07520591 (Valvosoft Outcomes Registry for Real-World Evidence) is: NOT_YET_RECRUITING.
When did Valvosoft Outcomes Registry for Real-World Evidence start?
Valvosoft Outcomes Registry for Real-World Evidence started on 2026-05-30.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.