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Valvosoft Outcomes Registry for Real-World Evidence

NCT07520591 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-14

No results posted yet for this 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.

Conditions

  • Aortic Valve Disease
  • Aortic Stenosis, Severe
  • Aortic Valve Calcification
  • Ultrasound Therapy
  • Heart Failure

Interventions

DEVICE

Valvosoft Treatment

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

Sponsors & Collaborators

  • T!Write

    collaborator UNKNOWN

  • Cardiawave SA

    lead INDUSTRY

Principal Investigators

  • Won-Keun Kim · University Hospital Schleswig-Holstein

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07520591 on ClinicalTrials.gov