Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03851068 · ClinicalTrials.gov registry record · NA

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

A NA study of Aortic Valve Stenosis and Aortic Valve Disease, sponsored by Foldax.

Active
Registry status
NA
Development phase
40
Enrollment target
5
Study locations

NCT03851068 is a NA study of Aortic Valve Stenosis and Aortic Valve Disease that is active but no longer recruiting, run by Foldax. The registered enrollment target is 40 participants, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03851068, a NA study of Aortic Valve Stenosis and Aortic Valve Disease, is active but no longer recruiting, sponsored by Foldax.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
40 participants
Enrollment target
5
Study locations

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 Studied

Aortic Valve Stenosis Aortic Valve Disease

Interventions

  • DEVICE Foldax Tria Aortic Valve

Study Locations (5)

Ohio

  • The Christ Hospital - Cincinnati
  • OhioHealth Riverside - Columbus

Indiana

  • St. Vincent Hospital - Indianapolis

Kansas

  • Ascension Via Christi St. Francis Hospital - Wichita

Michigan

  • William Beaumont Hospital - Detroit

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-06-18
Est. Completion 2026-12
Phase NA

Sponsor

Foldax

1 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03851068

The ClinicalTrials.gov registry entry for NCT03851068 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (96% lower). The listed sponsor is Foldax, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Foldax Tria Aortic Valve is the first listed.

NCT03851068 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Ohio, Indiana, Kansas.

Frequently Asked Questions

What is clinical trial NCT03851068 about?

NCT03851068 is a clinical study titled "Early Feasibility Study for the Foldax Tria Aortic Heart Valve". 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 clinica...

What is the current status of trial NCT03851068?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2019-06-18. Estimated completion is 2026-12.

What conditions does trial NCT03851068 study?

This clinical trial studies the following conditions: Aortic Valve Stenosis, Aortic Valve Disease.

What interventions are being tested in trial NCT03851068?

The interventions under investigation include: Foldax Tria Aortic Valve (DEVICE).

Who is sponsoring clinical trial NCT03851068?

This trial is sponsored by Foldax, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03851068 being conducted?

This trial has 5 study locations across Indiana, Kansas, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Aortic Valve Stenosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Aortic Valve Stenosis

All registered trials for this condition

Aortic Valve Disease

All registered trials for this condition

Indiana

All trials with a study site in Indiana

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.