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Trial record 31 of 228 for:    Recruiting, Not yet recruiting, Available Studies | Aortic stenosis

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

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ClinicalTrials.gov Identifier: NCT03779620
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Cardiawave SA

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Ultrasound treatment of Calcified aortic valve Not Applicable

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Ultrasound treatment of calcified aortic valve stenosis
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound treatment
Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement
Device: Ultrasound treatment of Calcified aortic valve
Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement




Primary Outcome Measures :
  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 size of the left ventricle internal diameter in diastole (cm)

  4. Device performance to modify valve structure as measured by echocardiography [ Time Frame: Immediately post-procedure ]
    Ability to modify the Left ventricular Ejection Fraction (%)

  5. Device performance to modify valve structure as measured by echocardiography [ Time Frame: Immediately post-procedure ]
    Ability to modify the Pressure Gradient (mmHg)


Secondary Outcome Measures :
  1. All-cause mortality up to two years [ Time Frame: Up to two years ]
    All-cause mortality and Major Adverse Events (MAEs) peri and post-procedure up to 30 days and then 3, 6, 12 and 24 months post operatively.

  2. Rate of 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. Most patients in this study will be class III and IV. Changes of classes (lower class means improvement) will be recorded and mean change of app patients at every time point will be measured. For every patients, a score of NYHA class over time will be presented.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    -

Exclusion Criteria:

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

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779620


Contacts
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Contact: Rene spaargaren, MD +33686300519 rene.spaargaren@cardiawave.com

Locations
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France
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Emmanuel MESSAS, Prof       emmanuel.messas@aphp.fr   
Principal Investigator: Emmanuel MESSAS, Prof         
Sub-Investigator: Guillaume GOUDOT, Dr         
Sub-Investigator: Christian SPAULDING, Prof         
Netherlands
Amphia Hospital Recruiting
Breda, Netherlands, 4818CK
Contact: Alexander IJsselmuiden, MD, PhD         
Principal Investigator: Alexander IJsselmuiden, MD, PhD         
Sub-Investigator: Peter den Heijer, MD, PhD         
Sponsors and Collaborators
Cardiawave SA
Investigators
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Principal Investigator: Emmanuel Messas, MD HGEP Paris, France

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Responsible Party: Cardiawave SA
ClinicalTrials.gov Identifier: NCT03779620     History of Changes
Other Study ID Numbers: CW19-01
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cardiawave SA:
symptomatic
aortic valve
stenosis
ultrasound
non-invasive

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction