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Transcatheter Valve Replacement

Transcatheter Valve Intervention for Tricuspid Regurgitation

N/A

Recruiting

Research Sponsored by Jenscare Innovation Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Age ≥18 years at time of consent

* Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days and at 1 year post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new device, the LuX-Valve Plus System, in patients with severe tricuspid regurgitation who are not suitable for surgery. The study will evaluate how

Who is the study for?

This trial is for adults over 18 with severe heart murmur or tricuspid valve regurgitation, who are symptomatic but considered unsuitable for surgery by a Heart Team. They must understand the study and consent to participate, be on stable diuretic medication, and have their condition confirmed by specialized labs.

What is being tested?

The LuX-Valve Plus System is being tested in this trial. It's a non-surgical procedure designed to replace the tricuspid valve through a vein (transcatheter intervention) in patients at high risk from traditional surgery.

What are the potential side effects?

While specific side effects aren't listed here, transcatheter interventions can generally include bleeding, infection at the catheter insertion site, heart rhythm problems (arrhythmias), or damage to blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My heart valve leak is severe or worse, confirmed by an echo.

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My heart condition limits my physical activity.

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I understand the study details and can give my written consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 days and at 1 year post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30 days and at 1 year post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days and at 1 year post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

- Incidence of major adverse events at 30 days post procedure

- Post-procedural TR Remission Rate

Secondary study objectives

Acute Secondary Endpoints - Clinical success Rate

Acute Secondary Endpoints - Intraprocedural success Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: : LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System)Experimental Treatment1 Intervention

The LuX-Valve Plus System is intended for the treatment of patients with severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery.

0 / 4Eligibility criteria met