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Clinical Trials/NL-OMON55716
NL-OMON55716
Completed
Not Applicable

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. - VALVOSOFT® FIM-STUDY

CARDIAWAVE SA.0 sites15 target enrollmentTBD
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Conditionssevere aortic valve stenosis / severely calcified aortic valve has caused a stenosis10046973

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
severe aortic valve stenosis / severely calcified aortic valve has caused a stenosis
Sponsor
CARDIAWAVE SA.
Enrollment
15
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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