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CompletedNCT03371524ARYELUpdated Oct 5, 2021

A Prospective RegistrY of Cardiac Echographic Loops

An observational study in Calcified Aortic Valve, sponsored by Cardiawave SA. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-05.

Sponsored by Cardiawave SA · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Calcified Aortic Valve
03

In context

Aortic Valve, Calcification of

44 studies on the registry are indexed under Aortic Valve, Calcification of; 15 are open to participants now.

This study's enrollment of 90 is below the median of 225 across 20 observational studies indexed under Aortic Valve, Calcification of.

Browse Aortic Valve, Calcification of studies →

Lead sponsor

Cardiawave SA is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with diagnosed calcified aortic stenosis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Form
  • Patients affiliated to French social security or equivalent

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • Bioprosthesis_30 seconds loops

    Patient with calcified aortic stenosis on bioprosthesis: record of a 30 second loop during routine cardiac echography.

    Other: Cardiac Echography

Interventions

  • OtherCardiac Echography

    While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.

06

What researchers measure

Primary outcomes

  1. Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.

    Time frame: Through study completion, up to 6 months

07

Study locations

3 sites
  • CHU de Caen
    Caen, 14000, France
  • Hôpital Européen Georges Pompidou
    Paris, 75015, France
  • Hôpital Charles Nicolle
    Rouen, 76000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Jan 2019, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Dec 13, 2017
StartActual
Jul 19, 2017
Primary completionActual
Jan 15, 2019
CompletionActual
Feb 1, 2019
Last update
Oct 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03371524
Lead sponsor
Cardiawave SA
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Jul 19, 2017
Primary completion
Jan 15, 2019
Completion
Feb 1, 2019
Last update
Oct 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Cardiawave SA

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