Valvosoft Outcomes Registry for Real-World Evidence

Starting soon

Conditions studied: Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy, Heart Failure

In brief

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.

Key facts

Study ID

NCT07520591

Run by

Cardiawave SA

People needed

200

Starts

2026-05-30

Expected to finish

2028-06-30

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hopital Bichat — Paris, France
• Hopital Europeen Georges Pompidou — Paris, France
• CHU Rouen Hopital Charles Nicolle — Rouen, France
• Marienkrankenhaus — Hamburg, Germany
• University Hospital Schleswig Holstein Campus Kiel — Kiel, Germany
• RadboudUMC — Nijmegen, Netherlands

Full record on ClinicalTrials.gov

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