VALVOSOFT® Pivotal Study

NCT05235568 | Completed DMC

• 1 other identifier: CW21-02
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 11

Brief Summary

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

Conditions

Aortic Valve Calcification; Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Valve; Stenosis; Ultrasound; non invasive

Outcome Measures

Primary Outcomes (2)

• Safety endpoint

  Rate of MACE \< 25%

  at 30 days post-procedure

• Performance endpoint

  Improvement in clinical status assessed by means of a decrease in NHYA functional class

  at 30 days post-procedure

Secondary Outcomes (9)

• Rate of MACE

  peri-procedureal, and at 3-, 6- and 12 months post procedure

• All cause mortality

  30 days, 3-, 6- and 12-months post procedure

• Rate of Stroke

  30 days, 3-, 6- and 12-months post procedure;

• AVA change at 30 days

  30 days post procedure

• AVA change in severity

  at 6- and 12 months

Study Arms (1)

Valvosoft

OTHER

Treatment with VALVOSOFT device

Device: VALVOSFT intervention

Interventions

VALVOSFT intervention DEVICE

Treatment of the calcific aorta valve by non-invasive ultrasound therapy

Valvosoft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
• Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
• Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and
• Age ≥18 years; and
• Subject willing to provide a written informed consent prior to participating in the study; and
• Subject who can comply with the study follow-up or other study requirements; and
• Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).

You may not qualify if:

• Subject with severe aortic regurgitation; or
• Subject with unstable arrhythmia not controlled by medical treatment; or
• Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
• Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or
• Cardiogenic shock or other hemodynamic instability; or
• Left Ventricular Ejection Fraction ≤30%; or
• Subject with mean AVAI \<0,24 cm²/m2; or
• History of heart transplant; or
• Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or
• Cardiac imaging evidence of vegetation; or
• Acute myocardial infarction (MI) within one month prior to enrolment; or
• Valve depth not suitable for NIUT (depth \>125mm with respect to the Valvosoft imaging probe); or
• Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or
• Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or
• Subject who is participating in another research study for which the primary endpoint has not been reached; or

Sponsors & Collaborators

• Cardiawave SA: lead
• QbD Clinical: collaborator

Study Sites (11)

CHU Lille Insitut Coeur Poumon

Lille, France

Location

Hopital Bichat Claude-Bernard

Paris, France

Location

Hopital Europeen Georges Pompidou

Paris, France

Location

CHU Reims Hopital Robert Debré

Reims, France

Location

CHU Rouen Hopital Charles Nicole

Rouen, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Kerckhoff-klinik

Bad Nauheim, 61231, Germany

Location

Marienkrankenhaus

Hamburg, Germany

Location

OLVG

Amsterdam, 1091 AC, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Radboudumc

Nijmegen, 6525 AG, Netherlands

Location

MeSH Terms

Conditions

Aortic Valve, Calcification of; Aortic Valve Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Spaulding, MD, PhD

  HEGP, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 11, 2022
• Study Start: June 15, 2022
• Primary Completion: August 17, 2023
• Study Completion: July 24, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); DE (2); NL (3)