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

NCT04665596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-20

No results posted yet for this study

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

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Ultrasound treatment

Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen

Sponsors & Collaborators

  • Cardiawave SA

    lead INDUSTRY

Principal Investigators

  • Emmanuel Messas, MD · Hospital Georges Pompidou, Paris, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2022-06-15
Completion
2024-05-23

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665596 on ClinicalTrials.gov