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NCT04024566
Rapid Non-invasive Detection of Aortic Stenosis
trial testing Vivio System in Heart Valve Diseases. Withdrawn.
18 July 2022
Quick facts
| Lead sponsor | Avicena LLC |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 14 August 2019 |
| Primary completion | 18 July 2022 |
| Estimated completion | 18 July 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vivio System
Conditions studied
- Heart Valve Diseases — all drugs for Heart Valve Diseases →
- Aortic Valve Disease — all drugs for Aortic Valve Disease →
- Heart Murmurs — all drugs for Heart Murmurs →
Sponsor
Avicena LLC
Who can join
Adults 60 to 95, any sex, with Heart Valve Diseases or Aortic Valve Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04024566
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vivio System
Trials testing the same drug.
- NCT04068402 — Vivio AS (Aortic Stenosis) Algorithm Optimization Study · NA · withdrawn
- NCT04066634 — Vivio AS (Aortic Stenosis) Detection Study · NA · completed
Other recruiting trials for Heart Valve Diseases
Currently open trials in the same condition.
- NCT07390903 — GLS in Difficult CPB Weaning · recruiting
- NCT07099859 — Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Unde · Phase 4 · recruiting
- NCT06215378 — Antagonization of Heparin With Protamine Sulfate After TAVI · Phase 3 · recruiting
- NCT06445231 — Echocardiography in Nursing Home · NA · recruiting
- NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting
Other Avicena LLC trials
Trials by the same sponsor.
- NCT05673174 — Avicena LVDP Validation Study in Healthy Volunteers · completed
- NCT05633004 — Avicena LVDP Validation Study · NA · completed
- NCT04068402 — Vivio AS (Aortic Stenosis) Algorithm Optimization Study · NA · withdrawn
- NCT04066634 — Vivio AS (Aortic Stenosis) Detection Study · 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 NCT04024566 (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 Avicena LLC
- Last refreshed: 20 July 2022
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/NCT04024566.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing