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Completed

NCT Number: NCT05235568

VALVOSOFT® Pivotal Study

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

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Key information

Conditions

Aortic Valve Calcification Aortic Valve Disease Aortic Valve Stenosis Aortic Valve, Calcification of Cardiovascular Diseases Constriction, Pathologic Heart Diseases Heart Valve Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lille Insitut Coeur Poumon, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or
  • Current endocarditis; or
  • Leukopenia (WBC <4000 cell/μL), anemia (Hgb <8 g/dL), thrombocytopenia (platelet count <15.000 cell/μL), or history of coagulopathy or hypercoagulable state; or
  • Life expectancy < 6 months due to non-cardiac co-morbid conditions; or
  • Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or
  • Subjects who do not have Social Security and who are under legal restraint; or
  • Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.

Treatment and study plan

VALVOSFT intervention

Device

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

Primary outcomes

  1. Safety endpoint

    Time frame: at 30 days post-procedure

    Rate of MACE < 25%

  2. Performance endpoint

    Time frame: at 30 days post-procedure

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

Secondary outcomes

  1. Rate of MACE

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

    Rate of major adverse and cerebral events

  2. All cause mortality

    Time frame: 30 days, 3-, 6- and 12-months post procedure

    All cause mortality

  3. Rate of Stroke

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

    Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)

  4. AVA change at 30 days

    Time frame: 30 days post procedure

    Change of 10% in of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) 30 days post procedure compared to baseline

  5. AVA change in severity

    Time frame: at 6- and 12 months

    Change in severity of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) at 6- and 12 months compared to baseline

  6. NYHA improvement

    Time frame: 3-, 6- and 12-months

    Change in clinical status assessed by means of a decrease in NYHA functional class

  7. Change in 6 minutes walk test

    Time frame: 30 days, 6- and 12 months

    Change in 6-minutes' walk test

  8. Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 30 days, 6-, and 12-months

    Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire

  9. Improvement of quality of life by EQ-5D

    Time frame: 30 days, 6-, and 12-months

    Improvement of quality of life by means of EQ-5D. The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Sponsors and collaborators

Lead sponsor

Cardiawave SA

Industry

Collaborators

  • QbD Clinical

Registry information

Official study title

Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 11, 2022
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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