Valvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Aortic Valve Disease; Aortic Valve Calcification; Ultrasound Therapy; Aortic Stenosis, Severe
• Intervention / Treatment: Device: Valvosoft Treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Dirk Pauwels; Phone Number: +33 (0)1 55 26 82 19; Email: dirk.pauwels@cardiawave.com
• Study Contact Backup: Name: Clemence PUPIER; Phone Number: +33 (0)1 55 26 82 19; Email: clemence.pupier@cardiawave.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suffering from calcific severe symptomatic AS, according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease, in adult patients not recommended by the local Heart Team for immediate TAVR/SAVR or refusing such interventions

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observational group; patients suffering from severe AS, not recommended for immediate AVR by local HEART Team or refusing an AVR and are treated with Valvosoft	Device: Valvosoft Treatment; non-invasive ultrasound therapy for the treatment of severe symptomatic calcific AS; Other Names: NIUT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MACE	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)	at 30 days post procedure

Collaborators and Investigators

• Sponsor: Cardiawave SA
• Collaborators: T!Write
• Investigators: Principal Investigator: Won-Keun Kim, University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Disease; Heart Failure; Aortic Valve Stenosis; Aortic Valve, Calcification of
• Other Study ID Numbers: CW26-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No