Clinical trials: Tricuspid Regurgitation (TR)
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients.
- Trial name
- FIM-TRICSTER (NCT07536724)
- Testing
- TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
- Where
- 2 sites in Uzbekistan
- Volunteers
- 10 people
- Sponsor
- Medira GmbH
Tricuspid Regurgitation (TR)
The TRICURE US IDE Pivotal Study
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
- Trial name
- TRICURE US IDE (NCT07528326)
- Testing
- TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System
- Where
- United States
- Volunteers
- 831 people
- Sponsor
- TRiCares
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR), Tricuspid Regurgitation
- Trial name
- NCT07140562
- Testing
- Tricuspid Annular Therapy System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- Tangent Cardiovascular Inc.
Tricuspid Regurgitation (TR)
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved…
- Trial name
- TREAT TR (NCT07586995)
- Testing
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation (TR), Valvular Heart Diseases
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide.
- Conditions
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- Trial name
- Robotic Lux (NCT07516145)
- Testing
- Transcatheter tricuspid valve replacement
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
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.
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
HFrEF, Tricuspid Regurgitation (TR)
Efficacy of Verciguat in TR and RV Failure
The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function.
- Trial name
- VERT-HF (NCT07668739)
- Testing
- Vericiguat
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Daejeon St. Mary's hospital
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
Atrial Fibrillation (AF), Tricuspid Regurgitation (TR)
Efficacy of Early Rhythm Control in AF With TR Patients
Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes.
- Trial name
- TRAF (NCT07607093)
- Testing
- Anti-arrhythmic drugs for rhythm control, DC cardioversion, catheter ablation for rhythm control, Usual care
- Where
- South Korea
- Volunteers
- 5,800 people
- Sponsor
- Samsung Medical Center
Tricuspid Insufficiency, Tricuspid Regurgitation (TR)
PASCAL Precision-GDMT Registry
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be…
- Conditions
- Tricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction, Left Ventricular (LV) Systolic Dysfunction
- Trial name
- PASCAL (NCT07578129)
- Volunteers
- 50 people
- Sponsor
- Ceric Sàrl
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Tricuspid Regurgitation (TR)
Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)
The study is focused on evaluation of the effectiveness of the Admittance Pulmonary Artery Catheter (PAC) system for assessing the right ventricular (RV) function in patients with tricuspid regurgitation (TR) prior to tricuspid…
- Trial name
- NCT07500025
- Testing
- Right Heart Catheterization
- Volunteers
- 8 people
- Sponsor
- Feldman Cardiology, PLLC
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.
Anxiety, Mitral Regurgitation
Virtual Reality Reduces Pre-Procedural Anxiety in TEER Patients, But Timing Seems Crucial
This study aims to evaluate the effect of adding virtual reality (VR) education to standard pre-procedural information on anxiety levels in patients scheduled for MitraClip or TricuspidClip procedures.
- Conditions
- Anxiety, Mitral Regurgitation, Tricuspid Regurgitation (TR), Mitraclip
- Trial name
- NCT07263659
- Testing
- Standard Education plus Virtual Reality (VR)
- Where
- Netherlands
- Volunteers
- 75 people
- Sponsor
- Abby Geerlings
Tricuspid Regurgitation (TR)
Ambulant Monitoring to Detect Hemodynamic and Electrical Impact of Severe Tricuspid Valve Regurgitation
This exploratory study aims to study the feasibility to detect early signs of disease progression in patients with severe TVR (grade ≥3/4) by monitoring electrical cardiac activity and correlating it with echocardiographic…
- Trial name
- NCT07043465
- Testing
- 14 days ambulatory rhythm monitoring
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Tricuspid Regurgitation (TR)
Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an…
- Trial name
- NCT06877520
- Testing
- Pivot Extend Tricuspid Regurgitation Spacer Device
- Where
- 3 sites in Georgia
- Volunteers
- 7 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Tricuspid Regurgitation (TR)
Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function
Tricuspid regurgitation (TR) is gaining increasing attention within the cardiological community due to its poor prognosis, challenging clinical presentation and difficult treatment.
- Trial name
- Tri-GuM (NCT06902922)
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Francesco Maisano
AV Block Complete, Tricuspid Regurgitation (TR)
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear.
- Trial name
- NCT06814574
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Functional Tricuspid Regurgitation (TR)
First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation
The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein.
- Trial name
- NCT03700918
- Testing
- DaVingiTR System
- Where
- 5 sites in Czechia, France and 1 more
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC