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NCT06568003 · ClinicalTrials.gov registry record · NA

TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)

A NA study of Tricuspid Regurgitation (TR), sponsored by Jenscare Innovation.

Active
Registry status
NA
Development phase
15
Enrollment target
3
Study locations

NCT06568003 is a NA study of Tricuspid Regurgitation (TR) that is active but no longer recruiting, run by Jenscare Innovation. The registered enrollment target is 15 participants. The trial reports 3 study locations across 3 states.

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The verdict

NCT06568003, a NA study of Tricuspid Regurgitation (TR), is active but no longer recruiting, sponsored by Jenscare Innovation.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
3
Study locations

Study Summary

The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).

Interventions

  • DEVICE Transcatheter Tricuspid Valve Intervention

Study Locations (3)

California

  • Cedars-Sinai Medical Center - Los Angeles

Michigan

  • Henry Ford Health System - Detroit

New York

  • Montefiore Medical Center - New York

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-09-26
Est. Completion 2030-10
Phase NA

Sponsor

Jenscare Innovation

1 total trials

What the Registry Record Tells You About NCT06568003

The ClinicalTrials.gov registry entry for NCT06568003 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jenscare Innovation, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tricuspid Regurgitation (TR) appearing as the primary indexed condition, and to 1 intervention - of which Transcatheter Tricuspid Valve Intervention is the first listed.

NCT06568003 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Michigan, New York.

Frequently Asked Questions

What is clinical trial NCT06568003 about?

NCT06568003 is a clinical study titled "TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)". The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients...

What is the current status of trial NCT06568003?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2024-09-26. Estimated completion is 2030-10.

What conditions does trial NCT06568003 study?

This clinical trial studies the following conditions: Tricuspid Regurgitation (TR).

What interventions are being tested in trial NCT06568003?

The interventions under investigation include: Transcatheter Tricuspid Valve Intervention (DEVICE).

Who is sponsoring clinical trial NCT06568003?

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

Where is trial NCT06568003 being conducted?

This trial has 3 study locations across California, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.