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Completed

NCT Number: NCT04665596

Valvosoft First-In-Human 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-Human

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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

Clinical Centre of Serbia

Belgrade, 11000, Serbia

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. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.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 according to ESC 2017 definition, including subjects with a bicuspid valve.
  • Patient is not eligible for TAVR/SAVR according to local Heart Team.
  • 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.
  • Patient is eligible for the Valvosoft procedure according to CRC.

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.

Treatment and study plan

Ultrasound treatment

Device

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

Other names: Ultrasound treatment of calcific aortic valve

Primary outcomes

  1. Safety: Rate of procedure related mortality

    Time frame: Up to 30 days

    Rate of procedure related mortality at 30 days

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

    Time frame: Immediately after the procedure

    Ability to modify the Left Ventricular Ejection Fraction (%)

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

    Time frame: Immediately after the procedure

    Ability to modify the Mean Pressure Gradient (mmHg)

Secondary outcomes

  1. All-cause mortality

    Time frame: Up to two years

    Number of patients that die during the course of the study and if so, how long aftre the procedure

  2. Rate of stroke

    Time frame: Up to two years

    Rate of stroke

  3. Change of severity of heart failure

    Time frame: At 1, 3,6,12 and 24 months

    Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest)

  4. Major Adverse Events

    Time frame: Up to 2 years

    Rate of Major Adverse Events (MAE) and number of patients with one or more MAE during the course of the study, an MAE defined as: Disabling stroke, Myocardial infarction or any clinically significant changes in biomarkers (CK, Troponin I - T) that would indicate damage to the heart structure, or clinically significant conduction disturbances requiring pacemaker implantation or persistent arrhythmias

  5. Adverse events

    Time frame: Up to 2 years

    Rate of all Adverse Events

  6. User Handeling

    Time frame: Immediately after the procedure

    User handling (questionnaire for operator + procedure duration

  7. Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient

    Time frame: At 1, 3, 6,1 2 and 24 months

    Long term maintenance of improvement of AVA and PG

  8. quality of life measured through Kansas City Cardiomyopathy Questionnaire

    Time frame: at 1, 3, 6, 12 and 24 months

    Improvement of quality of life by means of KCCQ

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-Human

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Dec 11, 2020
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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