Clinical trials: Tricuspid Valve Regurgitation
Heart Valve Diseases, Multiple Valve Disease, Unspecified
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves.
- Conditions
- Heart Valve Diseases, Multiple Valve Disease, Unspecified, Aortic Valve Disease, Aortic Valve Stenosis
- Trial name
- EACVI-MMVD (NCT06235385)
- Testing
- Intervention not provided
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Tricuspid Regurgitation
Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation
This study is a prospective design. Patients are severe tricuspid regurgitation (TR) (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment.
- Trial name
- NCT05671640
- Testing
- DragonFly-T Transcatheter Tricuspid Valve Repair System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Tricuspid Valve Regurgitation, Pacemaker
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.
- Conditions
- Tricuspid Valve Regurgitation, Pacemaker, ICD, Left Bundle Branch Area Pacing
- Trial name
- LITR (NCT07342036)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Hazem Omran
Atrial Fibrillation (AF), Tricuspid Regurgitation (TR)
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study
This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden…
- Trial name
- TRICUSPID-AF (NCT07617974)
- Where
- Italy
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Centro Cardiologico Monzino
Tricuspid Valve Insufficiency
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.
- Trial name
- TRAVEL (NCT04436653)
- Testing
- Tricuspid Valve Replacement System
- Where
- 8 sites in China
- Volunteers
- 150 people
- Sponsor
- Changhai Hospital
Aortic Stenosis, Mitral Regurgitation
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- MASTER-TAVI II (NCT07623083)
- Volunteers
- 300 people
- Sponsor
- Josep Rodes-Cabau
Tricuspid Valve Regurgitation, Nonrheumatic, Cardiac Catheterization
Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation
This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC…
- Conditions
- Tricuspid Valve Regurgitation, Nonrheumatic, Cardiac Catheterization, Heart Failure, Right Sided, Valve Regurgitation, Tricuspid
- Trial name
- TRACE-NL (NCT05628779)
- Testing
- TriClip TTVr system (Abbott Vascular), PASCAL TTVr system (Edwards Lifesciences)
- Where
- 6 sites in Netherlands
- Volunteers
- 150 people
- Sponsor
- St. Antonius Hospital
Tricuspid Regurgitation
Tricuspid Regurgitation in the ElderlY
Tricuspid regurgitation (TR) is the second most common VHD after MR. Its prevalence also increases with age, with an estimated incidence of up to 6% in elderly population.
- Trial name
- TREY (NCT05784883)
- Testing
- Echocardiography
- Where
- Egypt
- Volunteers
- 700 people
- Sponsor
- Al-Azhar University
Tricuspid Disease, Mitral Regurgitation
Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)
The surgical treatment of less than severe (≤2+/4+) functional tricuspid regurgitation (TR) in patient undergoing mitral valve surgery, is still controversial: some observational studies have suggested that performing tricuspid…
- Trial name
- NOSTRUM (NCT02996552)
- Testing
- M & T Repair Group, Mitral-Only Group
- Where
- 3 sites in Italy, Poland
- Volunteers
- 142 people
- Sponsor
- Ospedale San Raffaele
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
Heart Valve Diseases, Aortic Valve Stenosis
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique…
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic
- Trial name
- CORONATE (NCT05714293)
- Testing
- CT scan with contrast medium
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
- Trial name
- NCT06212193
- Testing
- Trillium™
- Where
- 10 sites in United States, Germany
- Volunteers
- 25 people
- Sponsor
- Innoventric LTD
Tricuspid Regurgitation
SGLT2 Inhibitor for Severe Tricuspid Regurgitation
The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated…
- Trial name
- Reduction-TR (NCT05686616)
- Testing
- Dapagliflozin Propanediol Hydrate 12.3 mg
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- Samsung Medical Center
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR).
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT (NCT02574650)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mitralign, Inc.
Tricuspid Regurgitation
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR).
- Trial name
- NCT05836493
- Testing
- Ring annuloplasty, Suture procedure
- Where
- Italy
- Volunteers
- 146 people
- Sponsor
- Michele De Bonis
Tricuspid Regurgitation
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
To evaluate the efficacy and safety of the transcatheter tricuspid valve ring system produced by Shanghai Huihe Medical Technology Co., Ltd.
- Trial name
- NCT05770648
- Testing
- Transcatheter Annuloplasty, The guidelines guide medication
- Volunteers
- 64 people
- Sponsor
- Shanghai Huihe Medical Technology Co., Ltd
Right Heart Insufficiency, Tricuspid Regurgitation
Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload
\"Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function.
- Trial name
- NCT06663566
- Testing
- Diagnose the patients right heart function as well as right heart fibrosis, Diagnose the patient's right heart function as well as right heart fibrosis
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Beijing Anzhen Hospital
Tricuspid Regurgitation
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled.
- Trial name
- NCT04289870
- Testing
- Trillium™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Innoventric LTD
Mitral Regurgitation, Mitral Stenosis
Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
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
- NCT02502448
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Konkuk University Medical Center
Tricuspid Regurgitation
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
- Trial name
- NCT06183684
- Testing
- Laplace TTVR System
- Where
- 10 sites in United States
- Volunteers
- 65 people
- Sponsor
- Laplace Interventional, Inc