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

NCT04665596 | Completed DMC

• 1 other identifier: CW19-01RS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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-Human

Conditions

Aortic Valve Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Safety: Rate of procedure related mortality

  Rate of procedure related mortality at 30 days

  Up to 30 days

• Device performance to modify valve structure as measured by echocardiography

  Ability to modify the Left Ventricular Ejection Fraction (%)

  Immediately after the procedure

• Device performance to modify valve structure as measured by echocardiography

  Ability to modify the Mean Pressure Gradient (mmHg)

  Immediately after the procedure

Secondary Outcomes (8)

• All-cause mortality

  Up to two years

• Rate of stroke

  Up to two years

• Change of severity of heart failure

  At 1, 3,6,12 and 24 months

• Major Adverse Events

  Up to 2 years

• Adverse events

  Up to 2 years

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

Interventions

Ultrasound treatment DEVICE

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

Also known as: Ultrasound treatment of calcific aortic valve

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 according to ESC 2017 definition, including subjects with a bicuspid valve.
• Patient is not eligible for TAVR/SAVR according to local Heart Team.
• 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.
• Patient is eligible for the Valvosoft procedure according to CRC.

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 (1)

Clinical Centre of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (2)

• Trifunovic-Zamaklar D, Velinovic M, Kovacevic-Kostic N, Messas E. Systematic brain magnetic resonance imaging and safety evaluation of non-invasive ultrasound therapy for patients with severe symptomatic aortic valve stenosis. Eur Heart J Cardiovasc Imaging. 2023 Jun 21;24(7):e108-e109. doi: 10.1093/ehjci/jead089. No abstract available.

  PMID: 37158997 BACKGROUND

• 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 BACKGROUND

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

  Hospital Georges Pompidou, 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 calcific aortic stenosis

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 11, 2020
• Study Start: December 23, 2019
• Primary Completion: June 15, 2022
• Study Completion: May 23, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)