A Prospective RegistrY of Cardiac Echographic Loops

NCT03371524 | Completed

• 1 other identifier: ARYEL
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Calcified Aortic Valve

Outcome Measures

Primary Outcomes (1)

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

  Through study completion, up to 6 months

Study Arms (3)

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

Cardiac Echography OTHER

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

Bioprosthesis_30 seconds loops; Native valves_30 and 60 seconds loops; Native valves_30 seconds loops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed calcified aortic stenosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiawave SA: lead

Study Sites (3)

CHU de Caen

Caen, 14000, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Charles Nicolle

Rouen, 76000, France

Location

MeSH Terms

Conditions

Aortic Valve, Calcification of

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 13, 2017
• Study Start: July 19, 2017
• Primary Completion: January 15, 2019
• Study Completion: February 1, 2019
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)