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Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement

NCT04717570 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-13

No results posted yet for this study

Summary

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Conditions

  • Mitral Valve Disease
  • Mitral Valve Stenosis
  • Mitral Valve Failure

Interventions

DEVICE

Foldax TRIA Mitral Valve

Mitral Valve Replacement

Sponsors & Collaborators

  • Foldax, Inc

    lead INDUSTRY

Principal Investigators

  • Frank Shannon, MD · Beaumont Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
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 NCT04717570 on ClinicalTrials.gov