Clinical trials: Severe Tricuspid Regurgitation
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.
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
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 Regurgitation
Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).
- Trial name
- NCT05006443
- Testing
- Cardiac Magnetic Resonance
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Mayo Clinic
Severe Tricuspid Regurgitation
TRICUS STUDY - Safety and Efficacy of the TricValve® Device
The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk…
- Trial name
- NCT03723239
- Testing
- TricValve® System
- Where
- Lithuania
- Volunteers
- 9 people
- Sponsor
- P+F Products + Features GmbH
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
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
Tricuspid Regurgitation
Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage.
- Trial name
- NCT04339192
- Testing
- Minimally Invasive Tricuspid Surgery
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Shanghai Zhongshan Hospital
Heart Failure Attributable to Severe Tricuspid Regurgitation
TRICuspid Intervention in Heart Failure Trial
Aims: Tricuspid regurgitation (TR) is a detrimental disease frequently diagnosed in patients with right-sided heart failure (HF).
- Trial name
- TRIC-I-HF (NCT04634266)
- Testing
- Transcatheter tricuspid valve treatment (TTVT)
- Where
- 28 sites in Germany
- Volunteers
- 360 people
- Sponsor
- LMU Klinikum
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
Severe Tricuspid Regurgitation
International Multisite Transcatheter Tricuspid Valve Therapies Registry
For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with…
- Trial name
- TriValve (NCT03416166)
- Testing
- Transcatheter Tricuspid Intervention
- Where
- Switzerland
- Volunteers
- 269 people
- Sponsor
- University of Zurich
Functional Tricuspid Regurgitation
Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation
This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.
- Trial name
- TRuE (NCT04173091)
- Testing
- No Intervention
- Where
- 5 sites in Germany, Israel
- Volunteers
- 2,000 people
- Sponsor
- Charite University, Berlin, Germany
Functional Tricuspid Regurgitation
Outcome of MC3 Ring Annuloplasty for Functional Tricuspid Regurgitation
This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease.
- Trial name
- NCT04078867
- Testing
- tricuspid valve repair
- Volunteers
- 105 people
- Sponsor
- Minia University
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
Tricuspid Regurgitation
Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million…
- Trial name
- TRIGISTRY (NCT05825898)
- Testing
- Surgery or Transcatheter tricuspid valve intervention
- Where
- 44 sites in United States, Austria and 8 more
- Volunteers
- 3,500 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Tricuspid Valve Disease, Heart Valve Diseases
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
- Conditions
- Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
- Trial name
- TRICAV-II (NCT06458907)
- Testing
- TricValve System, Optimal medical therapy
- Where
- 34 sites in United States
- Volunteers
- 780 people
- Sponsor
- P+F Products + Features USA Inc.
Tricuspid Regurgitation
Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)
The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.
- Trial name
- NCT04936802
- Testing
- Transcatheter tricuspid valve repair system (Trialign)
- Volunteers
- 5 people
- Sponsor
- Xijing Hospital
Congestive Heart Failure, Tricuspid Regurgitation
Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation.
- Trial name
- HERACLES-HFpEF (NCT04782908)
- Testing
- Transcatheter tricuspid valve edge-to-edge repair
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Heart Center Leipzig - University Hospital
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
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.
The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Cardio-Renal Syndrome, Frailty
- Trial name
- TriRenGe (NCT07464106)
- Testing
- Transcatheter edge-to-edge repair (TEER)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Robert Bosch Medical Center