A Prospective RegistrY of Cardiac Echographic Loops (ARYEL)

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.

Study Overview

• Status: Completed
• Conditions: Calcified Aortic Valve
• Intervention / Treatment: Other: Cardiac Echography

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CHU de Caen
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Rouen, France, 76000
    • Hopital Charles Nicolle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed calcified aortic stenosis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cardiawave SA

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2017
• Primary Completion (ACTUAL): January 15, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (ACTUAL): December 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ARYEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No