NCT07520591

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started May 2026

Typical duration for all trials

Geographic Reach
3 countries

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
May 2026Jun 2028

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 30, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 3, 2026

Last Update Submit

April 9, 2026

Conditions

Aortic Valve DiseaseHeart FailureAortic Stenosis, SevereAortic Valve CalcificationUltrasound Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Valvosoft TreatmentDEVICE

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

Also known as: NIUT
observational group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hopital Bichat

Paris, France

Location

Hopital Europeen Georges Pompidou

Paris, France

Location

CHU Rouen Hopital Charles Nicolle

Rouen, France

Location

Marienkrankenhaus

Hamburg, Germany

Location

University Hospital Schleswig Holstein Campus Kiel

Kiel, Germany

Location

RadboudUMC

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve StenosisAortic Valve, Calcification ofHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Won-Keun Kim

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Pauwels

CONTACT

+33 (0)1 55 26 82 19dirk.pauwels@cardiawave.com

Clemence PUPIER

CONTACT

+33 (0)1 55 26 82 19clemence.pupier@cardiawave.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 9, 2026

Study Start

May 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)FR(3)DE(2)