Valvosoft Outcomes Registry for Real-World Evidence

Condition(s) studied

Investigational drug(s) / intervention(s)

Valvosoft Treatment: non-invasive ultrasound therapy for the treatment of severe symptomatic calcific AS

Study 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.

Eligibility

Primary outcome measure(s)

• Rate of MACE — at 30 days post procedure
  Rate of MACE defined as a composite endpoint including all-cause mortality, myocardial infarction, stroke, myocardial infarction and rehospitalization for heart failure, up to 30-days post procedure(s)

Trial sites (6)

Other trials for the same condition