Clinical Trial: Valvosoft Outcomes Registry for Real-World Evidence

U.S., April 10 -- ClinicalTrials.gov registry received information related to the study (NCT07520591) titled 'Valvosoft Outcomes Registry for Real-World Evidence' on April 03.

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(R) non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS).

Valvosoft(R) 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.

Thi...