Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06568003

Tricuspid Regurgitation (TR)

ACTIVE_NOT_RECRUITING NA

Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System

NCT06714500

Tricuspid Regurgitation

ENROLLING_BY_INVITATION NA

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation

NCT05770648

Tricuspid Regurgitation

UNKNOWN NA

THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve

NCT04436653

Tricuspid Valve Insufficiency

RECRUITING NA

Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)

NCT04936802

Tricuspid Regurgitation

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High-surgical Risk Patients with Severe Tricuspid Regurgitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TTVR Screening

In this study ,235 patients were screened successed for TTVR with LuX-Valve via the trans-jugular vein, and 105 patients were screend failed

transcatheter tricuspid valve replacement

Intervention Type PROCEDURE

The LuX-valve was implanted under fluoroscopic and echocardiographic guidance via the transjugular vein approach. Once the delivery system was introduced, it was adjusted within the right heart chamber to be perpendicular to the tricuspid annulus. The anterior leaflet was grasped using two leaflet graspers, and the ventricular portion of the device component was gradually released. After deploying the atrial disc to ensure the elimination of TR, septal anchoring was performed, and the delivery system was subsequently withdrawn.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transcatheter tricuspid valve replacement

The LuX-valve was implanted under fluoroscopic and echocardiographic guidance via the transjugular vein approach. Once the delivery system was introduced, it was adjusted within the right heart chamber to be perpendicular to the tricuspid annulus. The anterior leaflet was grasped using two leaflet graspers, and the ventricular portion of the device component was gradually released. After deploying the atrial disc to ensure the elimination of TR, septal anchoring was performed, and the delivery system was subsequently withdrawn.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (i) age \> 18 years old; (ii) TR severity ≥ severe; (iii) New York Heart Association (NYHA) functional class ≥ Ⅱ; (iv) failed GDMT; (v) Euro-SCORE \> 4.

Exclusion Criteria

* (i) left ventricular ejection fraction \< 40%; (ii) systolic pulmonary arterial pressure \> 60 mmHg; (iii) prior TV surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No