Clinical trials: Tricuspid Regurgitation Functional
Tricuspid Regurgitation, Tricuspid Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
- Trial name
- TriBAND (NCT03779490)
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension.
- Trial name
- NCT05721417
- Testing
- Tricuspid valve surgery
- Where
- Italy
- Volunteers
- 172 people
- Sponsor
- Michele De Bonis
Tricuspid Valve Regurgitation, Heart Valve Diseases
2019-06 TRISCEND Study
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT04221490
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 228 people
- Sponsor
- Edwards Lifesciences
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
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.
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.
Functional Tricuspid Regurgitation
Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.
Interest in tricuspid valve disease has grown exponentially over the past few years, in response to increased interest in the poor prognosis of patients with functional tricuspid regurgitation (TR).
- Trial name
- NCT05836415
- Testing
- Tricuspid valve annuloplasty with 3D ring
- Where
- Italy
- Volunteers
- 168 people
- Sponsor
- Michele De Bonis
Functional Tricuspid Regurgitation
Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR
Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
- Trial name
- NCT05648838
- Testing
- Pivot Balloon Catheter
- Where
- 10 sites in South Korea
- Volunteers
- 7 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Functional Tricuspid Regurgitation
Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction
Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction…
- Trial name
- ECLIPSE-HF (NCT05209919)
- Testing
- Transthoracic Echocardiography
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
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 (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
Tricuspid Regurgitation Functional, Tricuspid Regurgitation
The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US
Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy…
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation, Severe Tricuspid Valve Regurgitation
- Trial name
- STTAR-US (NCT06700239)
- Testing
- MIA_T Device
- Volunteers
- 600 people
- Sponsor
- Micro Interventional Devices
Tricuspid Regurgitation, Right Ventricular Dilatation
Pharmacological Reduction of Right Ventricular Enlargement
Functional tricuspid regurgitation (TR) has been regarded as a secondary phenomenon of heart failure (HF), mitral valve (MV) disease or atrial fibrillation.
- Trial name
- PROVE (NCT04345796)
- Testing
- Carvedilol+Empagliflozin, Carvedilol, Empagliflozin
- Where
- 3 sites in South Korea
- Volunteers
- 56 people
- Sponsor
- Asan Medical Center
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
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
Heart Valve Incompetence, Atrial Fibrillation, Persistent
In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation
1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography.
- Trial name
- ASTRA (NCT05749107)
- Testing
- Echocardiography, Proteomic analyses
- Where
- 2 sites in Italy
- Volunteers
- 1,050 people
- Sponsor
- Istituto Auxologico Italiano
Tricuspid Regurgitation Functional
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following…
- Trial name
- NCT04890821
- Testing
- CI Percutaneous Ring Annuloplasty System
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC
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
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
Heart Valve Incompetence, Echocardiography, Transthoracic
The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
Prospective, multicenter, observational study to enroll consecutive patients with functional tricuspid regurgitation (FTR) with the primary aim to: Use patients' outcomes as a reference to try to define the threshold values for…
- Trial name
- FUTURE 3D (NCT05747404)
- Testing
- Echocardiography
- Where
- 4 sites in Italy, Romania
- Volunteers
- 1,500 people
- Sponsor
- Istituto Auxologico Italiano