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

NCT03779620 | Completed DMC

• 1 other identifier: CW19-01
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Aortic Valve Stenosis

Keywords

symptomatic; aortic valve; stenosis; ultrasound; non-invasive

Outcome Measures

Primary Outcomes (3)

• Safety: Rate of procedure related mortality at 30 days

  Rate of procedure related mortality at 30 days

  30 days post-procedure

• Device performance to modify valve structure as measured by echocardiography

  Ability to modify the Aortic Valve Area (mm2)

  Immediately post-procedure

• Device performance to modify valve structure as measured by echocardiography

  Ability to modify the Pressure Gradient (mmHg)

  Immediately post-procedure

Secondary Outcomes (7)

• All-cause mortality and major adverse events (MAE's)

  Up to 24 months

• Non-disabling stroke

  Up to 24 months

• Improvement of clinical status

  Up to 24 months

• Number of all Adverse Events (AEs)

  Up to 24 months

• User handeling of Valvosoft

  Immediately post-procedure

Study Arms (1)

Ultrasound treatment

EXPERIMENTAL

Ultrasound treatment of patients with symptomatic aortic valve stenosis who are not eligible for valve replacement

Device: Ultrasound treatment of Calcified aortic valve

Interventions

Ultrasound treatment of Calcified aortic valve DEVICE

Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement

Ultrasound treatment

Eligibility Criteria

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

You may qualify if:

• Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).
• Patient is not eligible for TAVR/SAVR .
• Age ≥18 years.
• Subjects who are willing to provide a written informed consent prior to participating in the study.
• Subjects who can comply with the study follow up or other study requirements.
• Subject eligible according to Clinical Review Committee

You may not qualify if:

• Subjects with any electrical device implanted.
• Subjects with unstable arrhythmia not controlled by medical treatment.
• Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
• Subjects with complex congenital heart disease.
• Chest deformity.
• Cardiogenic shock.
• History of heart transplant.
• Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.
• Thrombus in heart.
• Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment\*.
• Subjects who are pregnant or nursing.
• Subjects who are participating in another research study for which the primary endpoint has not been reached.

Sponsors & Collaborators

• Cardiawave SA: lead

Study Sites (2)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Amphia Hospital

Breda, 4818CK, Netherlands

Location

Related Publications (2)

• Messas E, Ijsselmuiden A, Trifunovic-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzic D, Milicevic V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. 2023 Dec 16;402(10419):2317-2325. doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.

  PMID: 37972628 RESULT

• Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available.

  PMID: 33486971 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Messas, MD

  HGEP Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ultrasound treatment of calcified aortic valve stenosis

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 19, 2018
• Study Start: March 13, 2019
• Primary Completion: January 15, 2022
• Study Completion: September 27, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); NL (1)