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Early Feasibility Study for the Foldax Tria Aortic Heart Valve

NCT03851068 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

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 Aortic 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

  • Aortic Valve Disease
  • Aortic Valve Stenosis

Interventions

DEVICE

Foldax Tria Aortic Valve

Aortic 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
2019-06-18
Primary Completion
2024-12-31
Completion
2026-12-31
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 NCT03851068 on ClinicalTrials.gov