POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy

NCT06650839 | Withdrawn DMC

• 1 other identifier: CW23-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.

Conditions

Moderate Aortic Valve Stenosis

Keywords

aortic stenosis; moderate; aortic valve; balloon valvuloplasty; TAVR; SAVR; Ultrasound; FUS; PCUT; NIUT

Outcome Measures

Primary Outcomes (2)

• Rate of MACE

  Rate of MACE defined as a composite of all-cause mortality, MI, stroke, rehospitalization for heart failure at 30 days.

  from baseline to 30 days FU

• Improvement in leaflet mobility

  Change in leaflet mobility measured by means of a change in AVA

  at 6 months FU compared to baseline

Secondary Outcomes (7)

• Rate of MACE

  at 6 , 12 , 18 , 24 months

• Rate of all Serious Adverse Events

  peri-procedural and at 30 days, 3 , 6 , 12 , 18 , 24 months

• Rate of Stroke

  at 30 days, 3 , 6 , 12 , 18 , 24 months

• Change of AS

  at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;

• Change in Quality of Life by means of KCCQ

  at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;

Study Arms (1)

Treatment MAS

EXPERIMENTAL

Subjects will be treated with Valvosoft, Ultrasound guided Non-Invasive Ultrasound Therapy (NIUT) medical device, to reduce the symptoms caused by moderate aortic stenosis

Device: NIUT

Interventions

NIUT DEVICE

Treatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft

Treatment MAS

Eligibility Criteria

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

You may qualify if:

• Aortic Valve Area (AVA) ≥1.0 cm2 ≤ 1.5 cm2 and either mean aortic Pressure Gradient (mPG) of \>25 - \< 40 mmHg or maximum velocity (Vmax) ≥3 ≤4 m/sec in normal flow conditions; or
• Normal-flow, low-gradient aortic stenosis (AS) with preserved ejection fraction (mean aortic Pressure Gradient (mPG) \<40 mmHg, Aortic Valve Area (AVA) ≥0.8 ≤1.0 cm2, Left Ventricular Ejection Fraction (LVEF) ≥50%, Stroke Volume Index (SVi) \>35 mL/m2);
• Age ≥18 years;

You may not qualify if:

• mPG ≥40 mmHg; or
• Severe aortic valve stenosis or other severe valve diseases; or
• Subject with severe aortic regurgitation; or
• Subjects with implanted mechanical or bioprosthetic valve in aortic position, or mechanical valve in any other positions; or
• Heart failure with a NYHA 3 or 4; or
• Cardiogenic shock or other hemodynamic instability; or
• LVEF ≤50%; or
• History of heart transplant; or
• Subject with a significant kidney disease (eGFR ≤30 mL/min/1.73 m2) or subject is on dialysis; or
• Subject with uncontrolled hypertension defined as systolic Blood Pressure (BP) ≥160 mmHg and/or a diastolic BP ≥100 mmHg (mean of 3 measurements for both assessments); or
• Cardiac imaging evidence of vegetation; or
• Current endocarditis; or 13 Subject has a documented history of cardiac amyloidosis; or
• \. Acute Myocardial Infarction (MI) ≤1 month prior to enrolment; or 15. Stroke or Transient Ischemic attack (TIA) ≤1 month prior to enrollment; or 16. Balloon Aortic Valvuloplasty (BAV) ≤3 months prior to enrollment; or 17. Leukopenia (WBC \<4000 cell/μL), anemia (Hgb \< 8 g/dL), thrombocytopenia (platelet count \<50.000 cell/μL), or history of coagulopathy or hypercoagulable state.

Sponsors & Collaborators

• Cardiawave SA: lead
• Micro Cro: collaborator
• TWrite: collaborator

Study Sites (1)

University Clinical Centre Serbia

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Milos Velinovic, MD, PhD

  University Clinical Centre Serbia

  PRINCIPAL INVESTIGATOR

• Danijela Trifunovic-Zamklar, MD, PhD

  University Clinical Centre Serbia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 21, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)