Who is sponsoring NCT03484780?

NCT03484780 is sponsored by VisCardia Inc..

What drugs are being tested in NCT03484780?

Interventions in NCT03484780: VisONE ADS.

What condition does NCT03484780 study?

NCT03484780 studies Heart Failure With Reduced Ejection Fraction, HFrEF.

Is NCT03484780 still recruiting?

NCT03484780 is currently completed. Last updated 20 May 2020.

Last reviewed 2020-05-20 · How we verify

NCT03484780

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

VisONE Heart Failure Study: Pilot

Completed NA Last updated 20 May 2020

What this trial tests

NA trial testing VisONE ADS in Heart Failure With Reduced Ejection Fraction, HFrEF in 15 participants. Completed in 12 December 2019.

Timeline

25 July 2018

Primary endpoint
12 December 2019

12 December 2019

Quick facts

Lead sponsor	VisCardia Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	25 July 2018
Primary completion	12 December 2019
Estimated completion	12 December 2019
Sites	3 locations across Georgia, Ukraine

Drugs / interventions tested

VisONE ADS

Conditions studied

Heart Failure With Reduced Ejection Fraction, HFrEF — all drugs for Heart Failure With Reduced Ejection Fraction, HFrEF →

Sponsor

VisCardia Inc. — full company profile →

Who can join

18 and older, any sex, with Heart Failure With Reduced Ejection Fraction, HFrEF. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system for 12 months.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review.
Fudim M, Abraham WT, von Bardeleben RS, Lindenfeld J, et al · · 2021 · cited 66× · PMID 34446165 · DOI 10.1016/j.jacc.2021.06.040
Novel Therapeutic Devices in Heart Failure.
Guzik M, Urban S, Iwanek G, Biegus J, et al · · 2022 · cited 5× · PMID 35893394 · DOI 10.3390/jcm11154303
Abstracts of the Heart Failure 2019 and the World Congress on Acute Heart Failure, 25-28 May 2019, Megaron Athens International Conference Centre, Greece.
· 2019 · cited 5× · PMID 32745277 · DOI 10.1002/ejhf.1488
Synchronized Diaphragmatic Stimulation for Heart Failure With a Reduced Left Ventricular Ejection Fraction Using the VisONE System: A First-in-Patient Study With Extended Population.
Jorbenadze A, Goldberg LR, Shaburishvili T, Zuber M, et al · · 2022 · cited 3× · PMID 37288118 · DOI 10.1016/j.shj.2022.100103

Verify or expand the search:

Other VisCardia Inc. trials

Trials by the same sponsor.

NCT05592392 — RECOVER-HF Pilot Study of SDS in Heart Failure · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03484780 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VisCardia Inc.
Last refreshed: 20 May 2020

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/NCT03484780.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing