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VALVOSOFT® Pivotal Study

NCT05235568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-20

No results posted yet for this study

Summary

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

Conditions

  • Aortic Valve Calcification
  • Aortic Valve Stenosis

Interventions

DEVICE

VALVOSFT intervention

Treatment of the calcific aorta valve by non-invasive ultrasound therapy

Sponsors & Collaborators

  • QbD Clinical

    collaborator INDUSTRY

  • Cardiawave SA

    lead INDUSTRY

Principal Investigators

  • Christian Spaulding, MD, PhD · HEGP, Paris, France

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2023-08-17
Completion
2024-07-24

Countries

  • France
  • Germany
  • Netherlands

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 NCT05235568 on ClinicalTrials.gov