A Prospective RegistrY of Cardiac Echographic Loops

Completed

• Conditions: Calcified Aortic Valve
• Interventions: Other: Cardiac Echography

• Registration Number: NCT03371524
• Lead Sponsor: Cardiawave SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-19
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-13
• Primary Completion: 2019-01-15
• Study Completion: 2019-02-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Native valves_30 seconds loops	Cardiac Echography	Patient with calcified aortic stenosis on native valve: record of a 30 second loop during routine cardiac echography.
Native valves_30 and 60 seconds loops	Cardiac Echography	Patient with calcified aortic stenosis on native valve: record of a 30 second loop and a 60 second loop during routine cardiac echography.
Bioprosthesis_30 seconds loops	Cardiac Echography	Patient with calcified aortic stenosis on bioprosthesis: record of a 30 second loop during routine cardiac echography.

Primary Outcome Measures

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

Trial Locations

Locations (3)

CHU de Caen; 🇫🇷 Caen, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France