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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Ultrasound treatment of Calcified aortic valve

• Registration Number: NCT03779620
• 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-man

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. This is a FIM study

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-03-13
• Primary Completion: 2022-01-15
• Study Completion: 2023-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve).

2. Patient is not eligible for TAVR/SAVR .

3. Age ≥18 years.

4. Subjects who are willing to provide a written informed consent prior to participating in the study.

5. Subjects who can comply with the study follow up or other study requirements.

6. Subject eligible according to Clinical Review Committee

Exclusion Criteria

1. Subjects with any electrical device implanted.

2. Subjects with unstable arrhythmia not controlled by medical treatment.

3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.

4. Subjects with complex congenital heart disease.

5. Chest deformity.

6. Cardiogenic shock.

7. History of heart transplant.

8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.

9. Thrombus in heart.

10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*.

11. Subjects who are pregnant or nursing.

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Non-disabling stroke	Up to 24 months	Rate of stroke at 1,3,6, 12 and 24 months
Improvement of clinical status	Up to 24 months	Improvement of New York Heart Association class (I-IV - stage of severity of heart failure - I=no symptoms, IV= symptoms at rest) at 1,3,6,12, and 24 months.
Number of all Adverse Events (AEs)	Up to 24 months	Rate of AE's reported at at 1, 3, 6, 12 and 24 months
User handeling of Valvosoft	Immediately post-procedure	User handling (questionnaire for operator + procedure duration) immediately post-procedure
Improvement of quality of life	upto 24 months	Improvement of quality of life by means of Kansas City Cardiomyopathy Questionnaire at 1, 3, 6, 12 and 24 months
All-cause mortality and major adverse events (MAE's)	Up to 24 months	Rate of all-cause mortality and MAE's peri and postprocedure and at 1, 3, 6, 12 and 24 months post operatively.
Long term maintenance of improvement of AVA and PG	upto 24 months	Long term maintenance of improvement of AVA and PG at 3, 6, 12 and 24 months

Trial Locations

Locations (2)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Amphia Hospital; 🇳🇱 Breda, Netherlands