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Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study

NCT06680427 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-03

No results posted yet for this study

Summary

The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.

Conditions

  • Aortic Stenosis Symptomatic

Interventions

DEVICE

Siegel Transcatheter Aortic Valve (TAVR)

Replacement of native aortic valve with the Siegel Transcatheter Aortic Valve (TAVR) by a transfemoral approach.

Sponsors & Collaborators

  • MiRus

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

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 NCT06680427 on ClinicalTrials.gov