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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: Active NA study of Tricuspid Regurgitation (TR), sponsored by Jenscare Innovation.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Defined as: Post-procedural TR of moderate or less (TR≤2+) without clinically significant paravalvular leak (PVL) on a transthoracic echocardiography (TTE) at 30 days post- procedure (Assessed by the Echocardiography Core Lab using a 5-grade classification)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-09-26 |
| Est. Completion | 2030-10 |
| Phase | NA |
What the registry record for NCT06568003 still lists
NCT06568003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06568003's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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