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A Prospective RegistrY of Cardiac Echographic Loops (ARYEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371524
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Cardiawave SA

Study Description
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Brief Summary:

CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e. TAVI (Transcatheter Aortic Valve Implantation) or SAVR (Surgical Aortic Valve Replacement). This therapy consists in focusing ultrasound on aortic valve transthoracically and use high energy to soften calcification from the target valve. In order to do so, we develop a device able to deliver high energy ultrasounds to a targeted valve thanks to the synchronization of patient hearts live imaging and therapy in real time.

Live imaging will use an algorithm to realize 'valve tracking': an automatic detection of aortic valve position and shape as fast as image acquisition time. In order to develop and validate this 'valve tracking' algorithm, CARDIAWAVE requires cardiac echographic loops of patients with aortic valve calcification, with 30 seconds or 60 seconds recording.

The objective of the present study is to develop and validate the 'valve tracking' processing algorithm of CARDIAWAVE.

ARYEL is a prospective, multicenter, non-interventional study.


Condition or disease Intervention/treatment
Calcified Aortic Valve Other: Cardiac Echography

Study Design
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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective RegistrY of Cardiac Echographic Loops
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : February 1, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Native valves_30 seconds loops
Patient with calcified aortic stenosis on native valve: record of a 30 second loop during routine cardiac echography.
 Other: Cardiac Echography
While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.
Native valves_30 and 60 seconds loops
Patient with calcified aortic stenosis on native valve: record of a 30 second loop and a 60 second loop during routine cardiac echography.
 Other: Cardiac Echography
While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.
Bioprosthesis_30 seconds loops
Patient with calcified aortic stenosis on bioprosthesis: record of a 30 second loop during routine cardiac echography.
 Other: Cardiac Echography
While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.


Outcome Measures
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Primary Outcome Measures :
  1. Validation of the 'valve tracking' processing algorithm of CARDIAWAVE. [ Time Frame: Through study completion, up to 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosed calcified aortic stenosis.
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 y.o
  • Patients with a confirmed diagnosis of Aortic valve calcification on native valve or bioprosthesis
  • Patients with planned cardiac transthoracic echography for 'Aortic valve calcification' follow-up
  • Patients who have signed Informed Consent Form
  • Patients affiliated to French social security or equivalent

Exclusion Criteria:

  • Patients allergic to echographic gel
  • Patients with "hostile thorax": serious cutaneous irradiation injury or major thoracic deformity.
  • Low echogenicity
  • Patients with mild or high abundance pericardic effusion
Contacts and Locations
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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): NCT03371524


Locations
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France
CHU de Caen
Caen, France, 14000
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Charles Nicolle
Rouen, France, 76000
Sponsors and Collaborators
Cardiawave SA
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Cardiawave SA
ClinicalTrials.gov Identifier: NCT03371524    
Other Study ID Numbers: ARYEL
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
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