Clinical trials: Tricuspid Valve Disease
Tricuspid Valve Regurgitation
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…
- Trial name
- NCT05194423
- Testing
- Tricuspid Valve Replacement System via jugular vein
- Where
- 9 sites in China
- Volunteers
- 150 people
- Sponsor
- Changhai Hospital
Tricuspid Valve Insufficiency
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates.
- Trial name
- NCT04522154
- Testing
- Magnet resonance imaging
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Tricuspid Valve Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid…
- Trial name
- TriCLASP (NCT04614402)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System
- Where
- 15 sites in Germany, Greece and 2 more
- Volunteers
- 300 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation, Tricuspid Valve Disease
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- Trial name
- VISTA (NCT05797519)
- Testing
- VDyne Transcatheter Tricuspid Valve Replacement System
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 120 people
- Sponsor
- VDyne, Inc.
Tricuspid Regurgitation
Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair
In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes.
- Trial name
- HERITAGE (NCT06309524)
- Testing
- Tricuspid transcatheter edge-to-edge repair
- Where
- Italy
- Volunteers
- 17 people
- Sponsor
- Istituto Auxologico Italiano
Tricuspid Regurgitation
Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
This study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. The primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events.
- Trial name
- NCT06926959
- Where
- 7 sites in China
- Volunteers
- 3,000 people
- Sponsor
- Sun Yat-sen University
Mitral Valve Disease, Coronary Artery Disease
Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation
The aim of our study was to investigate, whether enhancement of left atrial cryoablation by ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of surgical treatment of atrial fibrillation in…
- Conditions
- Mitral Valve Disease, Coronary Artery Disease, Tricuspid Valve Disease, Aortic Valve Disease
- Trial name
- NCT03239262
- Testing
- Concomitant Mapping and Radiofrequency Ablation, No intervention
- Volunteers
- 100 people
- Sponsor
- University Hospital Ostrava
Tricuspid Regurgitation
TriClip Japan Post-Approval Study
The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following…
- Trial name
- TriClip JP PAS (NCT07509658)
- Testing
- The TriClip System
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation (TR)
Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)
The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system.
- Trial name
- NCT07454980
- Testing
- TTVI with LuX-Valve Plus System, TTVI with EVOQUE
- Where
- 7 sites in United States, Canada
- Volunteers
- 680 people
- Sponsor
- Jenscare Innovation Inc.
Aortic Stenosis, Aortic Regurgitation
Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease
This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT07605624
- Testing
- Transcatheter Aortic Valve Replacement, Transcatheter Edge-to-Edge Repair, Transcatheter Tricuspid Valve Annuloplasty
- Where
- China
- Volunteers
- 5,500 people
- Sponsor
- Beijing Anzhen Hospital
Atrial Fibrillation, Functional Mitral Regurgitation
Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation
A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation, Functional Mitral Regurgitation, Functional Tricuspid Regurgitation
- Trial name
- NCT05920824
- Testing
- Echocardiogram
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Barts & The London NHS Trust
Tricuspid Regurgitation, Valvular Heart Disease
European Registry of Transcatheter Repair for Tricuspid Regurgitation
To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.
- Conditions
- Tricuspid Regurgitation, Valvular Heart Disease, Heart Failure
- Trial name
- EuroTR (NCT06307262)
- Testing
- T-TEER
- Where
- Germany
- Volunteers
- 3,000 people
- Sponsor
- LMU Klinikum
Functional Tricuspid Regurgitation
Ring Versus Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases
This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring annuloplasty in Rheumatic Heart Disease patients…
- Trial name
- NCT02721524
- Testing
- Tricuspid Annuloplasty
- Where
- Nepal
- Volunteers
- 86 people
- Sponsor
- Shahid Gangalal National Heart Centre
Tricuspid Regurgitation
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate…
- Trial name
- NCT05556460
- Testing
- DragonFly-T Transcatheter Tricuspid Valve Repair System, Medical therapy
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.
- Trial name
- Contour3D (NCT01585779)
- Testing
- Contour 3D® implant for tricuspid valve repair, Tri-Ad® implant for tricuspid valve repair
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Regurgitation (TR)
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.
- Trial name
- NCT06568003
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Jenscare Innovation Inc.
Mitral Regurgitation, Mitral Stenosis
Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery
The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT06664320
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- 2 sites in South Korea
- Volunteers
- 70 people
- Sponsor
- Konkuk University Medical Center
Tricuspid Valve Disease
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring…
- Trial name
- NCT02397668
- Testing
- CorMatrix Cor TRICUSPID ECM Valve
- Where
- 4 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Corvivo Cardiovascular, Inc.
Carcinoid Heart Disease, Neuroendocrine Tumors
CardioNETPOL National Registry of Carcinoid Heart Disease
Carcinoid tumors are neuroendocrine tumors (NETs), most commonly originating from the gastrointestinal tract, that may secrete bioactive substances such as serotonin.
- Conditions
- Carcinoid Heart Disease, Neuroendocrine Tumors, Carcinoid Syndrome, Valvular Heart Disease Patients
- Trial name
- CardioNETPOL (NCT07450287)
- Testing
- Observational Registry of Carcinoid Heart Disease
- Where
- Poland
- Volunteers
- 120 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Tricuspid Regurgitation, Right Heart Failure
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients.
- Conditions
- Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular, Cardiac Remodeling, Atrial
- Trial name
- NCT05179616
- Testing
- Transcatheter edge-to-edge tricuspid valve repair
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Helios Klinikum Pforzheim