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Not yet recruiting NCT07520591

Valvosoft Outcomes Registry for Real-World Evidence

— Observational Aortic Valve Disease Aortic Stenosis, Severe Aortic Valve Calcification Ultrasound Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Valvosoft Treatment.
Who it may be relevant to
Registry conditions: Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Germany, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Rate of MACE [Time frame: at 30 days post procedure]

Eligibility criteria

Inclusion criteria

  • Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease.
  • Not recommended by the local heart team for immediate TAVR/SAVR, or refusing such an intervention.
  • Willing to provide a written informed consent prior to participating in this Registry.
  • Able to comply with the follow up schedule or other Study requirements.

Exclusion criteria

  • Prosthetic aortic valve;
  • Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator;
  • Thoracic injured skin, presence of scar(s) and/or burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator;
  • Pregnant or breastfeeding Patient.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Hopital Bichat — Paris
  • Hopital Europeen Georges Pompidou — Paris
  • CHU Rouen Hopital Charles Nicolle — Rouen
Germany · 2 centers
  • Marienkrankenhaus — Hamburg
  • University Hospital Schleswig Holstein Campus Kiel — Kiel
Netherlands · 1 center
  • RadboudUMC — Nijmegen

Identifiers

NCT: NCT07520591 · CW26-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗