A Prospective RegistrY of Cardiac Echographic Loops

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03371524

Acronym

ARYEL

Enrollment

Registered

2017-12-13

Start date

2017-07-19

Completion date

2019-02-01

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcified Aortic Valve

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.

Interventions

OTHERCardiac Echography

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.	Through study completion, up to 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026