Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis (NCT04665596) | Clinical Trial Compass
CompletedNot Applicable
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
Serbia10 participantsStarted 2019-12-23
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Safety: Rate of procedure related mortality
Timeframe: Up to 30 days
2
Device performance to modify valve structure as measured by echocardiography
Timeframe: Immediately after the procedure
3
Device performance to modify valve structure as measured by echocardiography