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Completed

NCT Number: NCT03779620

Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis

This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease 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

Hôpital Européen Georges Pompidou, Paris, France

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About this study

CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. This is a FIM study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
  • Patient is not eligible for TAVR/SAVR .
  • Age ≥18 years.
  • Subjects who are willing to provide a written informed consent prior to participating in the study.
  • Subjects who can comply with the study follow up or other study requirements.
  • Subject eligible according to Clinical Review Committee

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Exclusion criteria

  • Subjects with any electrical device implanted.
  • Subjects with unstable arrhythmia not controlled by medical treatment.
  • Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
  • Subjects with complex congenital heart disease.
  • Chest deformity.
  • Cardiogenic shock.
  • History of heart transplant.
  • Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.
  • Thrombus in heart.
  • Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*.
  • Subjects who are pregnant or nursing.
  • Subjects who are participating in another research study for which the primary endpoint has not been reached.

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Treatment and study plan

Ultrasound treatment of Calcified aortic valve

Device

Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement

Primary outcomes

  1. Safety: Rate of procedure related mortality at 30 days

    Time frame: 30 days post-procedure

    Rate of procedure related mortality at 30 days

  2. Device performance to modify valve structure as measured by echocardiography

    Time frame: Immediately post-procedure

    Ability to modify the Aortic Valve Area (mm2)

  3. Device performance to modify valve structure as measured by echocardiography

    Time frame: Immediately post-procedure

    Ability to modify the Pressure Gradient (mmHg)

Secondary outcomes

  1. All-cause mortality and major adverse events (MAE's)

    Time frame: Up to 24 months

    Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively.

  2. Non-disabling stroke

    Time frame: Up to 24 months

    Rate of stroke at 1,3,6, 12 and 24 months

  3. Improvement of clinical status

    Time frame: Up to 24 months

    Improvement of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) at 1,3,6,12, and 24 months.

  4. Number of all Adverse Events (AEs)

    Time frame: Up to 24 months

    Rate of AE's reported at at 1, 3, 6, 12 and 24 months

  5. User handeling of Valvosoft

    Time frame: Immediately post-procedure

    User handling (questionnaire for operator + procedure duration) immediately post-procedure

  6. Improvement of quality of life

    Time frame: upto 24 months

    Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months

  7. Long term maintenance of improvement of AVA and PG

    Time frame: upto 24 months

    Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months

Sponsors and collaborators

Lead sponsor

Cardiawave SA

Industry

Registry information

Official study title

Prospective, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Man

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Dec 19, 2018
Registry last updated
Oct 15, 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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