Last reviewed · How we verify
NCT03371524: ARYEL
A Prospective RegistrY of Cardiac Echographic Loops
trial testing Cardiac Echography in Calcified Aortic Valve in 90 participants. Completed in 1 February 2019.
15 January 2019
Quick facts
| Lead sponsor | Cardiawave SA |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 90 |
| Start date | 19 July 2017 |
| Primary completion | 15 January 2019 |
| Estimated completion | 1 February 2019 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Cardiac Echography
Conditions studied
- Calcified Aortic Valve — all drugs for Calcified Aortic Valve →
Sponsor
Cardiawave SA
Who can join
18 and older, any sex, with Calcified Aortic Valve. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03371524
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Cardiawave SA trials
Trials by the same sponsor.
- NCT07520591 — Valvosoft Outcomes Registry for Real-World Evidence · not yet recruiting
- NCT05235568 — VALVOSOFT® Pivotal Study · NA · completed
- NCT04665596 — Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis · NA · completed
- NCT03779620 — Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03371524 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cardiawave SA
- Last refreshed: 5 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03371524.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing