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Completed

NCT Number: NCT03371524

A Prospective RegistrY of Cardiac Echographic Loops

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.

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Key information

Conditions

Calcified Aortic Valve Aortic Valve, Calcification of

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Caen, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Echography

Other

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

Primary outcomes

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

    Time frame: Through study completion, up to 6 months

Sponsors and collaborators

Lead sponsor

Cardiawave SA

Industry

Registry information

Acronym: ARYEL

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Oct 5, 2021

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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