Who is sponsoring NCT03779620?

NCT03779620 is sponsored by Cardiawave SA.

What drugs are being tested in NCT03779620?

Interventions in NCT03779620: Ultrasound treatment of Calcified aortic valve.

What condition does NCT03779620 study?

NCT03779620 studies Aortic Valve Stenosis.

Is NCT03779620 still recruiting?

NCT03779620 is currently completed. Last updated 15 October 2024.

Last reviewed 2024-10-15 · How we verify

NCT03779620

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

Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis

Completed NA Last updated 15 October 2024

What this trial tests

NA trial testing Ultrasound treatment of Calcified aortic valve in Aortic Valve Stenosis in 30 participants. Completed in 27 September 2023.

Timeline

13 March 2019

Primary endpoint
15 January 2022

27 September 2023

Quick facts

Lead sponsor	Cardiawave SA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	13 March 2019
Primary completion	15 January 2022
Estimated completion	27 September 2023
Sites	2 locations across France, Netherlands

Drugs / interventions tested

Ultrasound treatment of Calcified aortic valve

Conditions studied

Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →

Sponsor

Cardiawave SA

Who can join

18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man

Publications & conference data

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

Histotripsy: the first noninvasive, non-ionizing, non-thermal ablation technique based on ultrasound.
Xu Z, Hall TL, Vlaisavljevich E, Lee FT. · · 2021 · cited 226× · PMID 33827375 · DOI 10.1080/02656736.2021.1905189
Histotripsy: A Method for Mechanical Tissue Ablation with Ultrasound.
Xu Z, Khokhlova TD, Cho CS, Khokhlova VA. · · 2024 · cited 49× · PMID 38346277 · DOI 10.1146/annurev-bioeng-073123-022334
Overview of Therapeutic Ultrasound Applications and Safety Considerations: 2024 Update.
Bader KB, Padilla F, Haworth KJ, Ellens N, et al · · 2025 · cited 23× · PMID 39526313 · DOI 10.1002/jum.16611
Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study.
Messas E, Ijsselmuiden A, Trifunović-Zamaklar D, Cholley B, et al · · 2023 · cited 21× · PMID 37972628 · DOI 10.1016/s0140-6736(23)01518-0
Research progress and clinical evaluation of histotripsy: a narrative review.
Li S, Wei Y, Zhang B, Li X. · · 2023 · cited 12× · PMID 37082680 · DOI 10.21037/atm-22-2578
Nanostrategies synergize with locoregional interventional therapies for boosting antitumor immunity.
Luo T, Ma K, Zhang Y, Xue Q, et al · · 2025 · cited 4× · PMID 40521175 · DOI 10.1016/j.bioactmat.2025.05.016
Revolutionizing cardiovascular care: the power of histotripsy.
Verma Y, Arachchige ASPM. · · 2024 · cited 2× · PMID 38217765 · DOI 10.1007/s40477-023-00848-7

Verify or expand the search:

Other recruiting trials for Aortic Valve Stenosis

Currently open trials in the same condition.

NCT07455292 — Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging · NA · recruiting
NCT07008911 — CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation · NA · recruiting
NCT07145463 — Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aorti · NA · recruiting
NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting

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
NCT03371524 — A Prospective RegistrY of Cardiac Echographic Loops · 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 NCT03779620 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Cardiawave SA
Last refreshed: 15 October 2024

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/NCT03779620.

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