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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Ultrasound treatment

• Registration Number: NCT04665596
• Lead Sponsor: Cardiawave SA

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

Study Timeline

• Study Start: 2019-12-23
• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Primary Completion: 2022-06-15
• Study Completion: 2024-05-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety: Rate of procedure related mortality	Up to 30 days	Rate of procedure related mortality at 30 days
Device performance to modify valve structure as measured by echocardiography	Immediately after the procedure	Ability to modify the Mean Pressure Gradient (mmHg)

Secondary Outcome Measures

Name	Time	Method
Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient	At 1, 3, 6,1 2 and 24 months	Long term maintenance of improvement of AVA and PG
Adverse events	Up to 2 years	Rate of all Adverse Events
Change of severity of heart failure	At 1, 3,6,12 and 24 months	Change of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest)
All-cause mortality	Up to two years	Number of patients that die during the course of the study and if so, how long aftre the procedure
Rate of stroke	Up to two years	Rate of stroke
Major Adverse Events	Up to 2 years	Rate of Major Adverse Events (MAE) and number of patients with one or more MAE during the course of the study, an MAE defined as: Disabling stroke, Myocardial infarction or any clinically significant changes in biomarkers (CK, Troponin I - T) that would indicate damage to the heart structure, or clinically significant conduction disturbances requiring pacemaker implantation or persistent arrhythmias
User Handeling	Immediately after the procedure	User handling (questionnaire for operator + procedure duration
quality of life measured through Kansas City Cardiomyopathy Questionnaire	at 1, 3, 6, 12 and 24 months	Improvement of quality of life by means of KCCQ

Trial Locations

Locations (1)

Clinical Centre of Serbia; 🇷🇸 Belgrad, Serbia