Clinical Research Directory

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

TRISCEND II Pivotal Trial

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion

The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead. To collect this data, a transthoracic echocardiogram (TTE) with 3D imaging of the tricuspid valve (TV) will be performed before and after pacemaker implantation, with particular emphasis on assessing the tricuspid valve. Additionally, routine follow-up visits will be conducted at 6 and 12 months post-intervention, during which a TTE, ECG, NT-proBNP measurement, and pacemaker check will be performed.

2019-06 TRISCEND Study

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

The TRICURE EFS Study

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.

Clinical Study of the inQB8 TTVR System

Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

The TRICURE EU Pivotal Study

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device (bRIGHT)

The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

TRISCEND JAPAN Study

A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.

TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique

In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER. The main endpoints are: * Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade * Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)

THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein

The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.