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

NCT ID: NCT04665596

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-23
• Study Completion Date: 2024-05-23

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

Detailed Description

CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.This is a FIM study

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound treatment

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

Group Type: EXPERIMENTAL

Ultrasound treatment

Intervention Type: DEVICE

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

Interventions

Ultrasound treatment

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

Intervention Type: DEVICE

Other Intervention Names

Ultrasound treatment of calcific aortic valve

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiawave SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel Messas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Georges Pompidou, Paris, France

Locations

Clinical Centre of Serbia

Belgrade, , Serbia

Countries

Serbia

References

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.

Reference Type: BACKGROUND

PMID: 37158997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37972628 (View on PubMed)

Other Identifiers

CW19-01RS

Identifier Type: -

Identifier Source: org_study_id