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.

Completed

• Conditions: severe aortic valve stenosis / severely calcified aortic valve has caused a stenosis; 10046973

• Registration Number: NL-OMON55716
• Lead Sponsor: CARDIAWAVE SA.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Subjects suffering from severe symptomatic aortic valve stenosis according
to ESC 2017 definition, including subjects with a bicuspid valve.
2. Patient is not eligible for TAVR/SAVR according to local Heart Team.
3. Age >=18 years.
4. Subjects who are willing to provide a written informed consent prior to
participating in this clinical investigation.
5. Subjects who can comply with the study follow-up or other study requirements.
6. Patient is eligible for the Valvosoft procedure according to CRC.

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, 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>Rate of procedure related mortality up to 30 days post-procedure.<br /><br>Performance:<br /><br>1. Level of improvement in leaflet mobility by means of decrease in<br /><br>transvalvular pressure gradient (PG) immediately post procedure compared to<br /><br>baseline (echocardiography).<br /><br>2. Level of decrease in severity of aortic stenosis by means of increase in<br /><br>aortic valve area (AVA) (echocardiography) immediately post procedure compared<br /><br>to baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>1. Rate of MAEs peri procedural and at 1, 3, 6, 12 and 24 months post procedure.<br /><br>2. All-cause mortality at 1, 3, 6, 12 and 24 months post procedure.<br /><br>3. Rate of stroke at 1, 3, 6, 12 and 24 months.<br /><br>4. Rate of all adverse events up to 24 months.<br /><br>Performance:<br /><br>Device usability<br /><br>1. User handling (questionnaire for operator + procedure duration).<br /><br>2. Long term maintenance of improvement of AVA and PG at 1, 3, 6, 12 and 24<br /><br>months. The 6 months assessment being an important secondary endpoint for<br /><br>regulatory purposes.<br /><br>Effectiveness:<br /><br>1. Improvement of clinical status assessed by means of NYHA functional class,<br /><br>presyncope/syncope and angina at 1, 3, 6, 12 and 24 months.<br /><br>2. Improvement of quality of life by means of KCCQ at 1, 3, 6, 12 and 24<br /><br>months.</p><br>