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

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. According to ClinicalTrials.gov, the official US trial registry.

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.

Primary Outcome

The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis

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
Foldax

1 total trials

What the registry record for NCT03851068 still lists

NCT03851068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (96% lower).

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 lists 5 locations in 4 states (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.

Where NCT03851068's enrollment target sits among peer trials

40 29th of 30 higher than 2 of 30 other Aortic Valve Stenosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01306019 · 40 participants · Phase 1

    Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)

  • NCT01608152 · 40 participants

    Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors

  • NCT01668082 · 40 participants · NA

    An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

  • NCT02015013 · 40 participants · Phase 2

    Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT03851068, the US trial registry maintained by the National Library of Medicine. NCT03851068 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.