Clinical trials: Functional Tricuspid Regurgitation
Tricuspid Regurgitation
Clinical Study of Edwards Cardioband FIT Valve Repair System
Clinical Study of the Edwards Cardioband FIT Repair System
- Trial name
- NCT03382457
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
Tricuspid Cardiopulmonary Exercise Study
Tricuspid regurgitation (TR), which in close to 90% of cases is functional as a consequence of left-sided heart failure, left heart valve abnormalities or pulmonary (vascular) disease, is associated with adverse patient outcomes…
- Trial name
- TRCPET (NCT04559256)
- Testing
- Cardiopulmonary Exercise Testing
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
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
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
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
Lymphatic Insufficiency, Heart Failure
Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation
The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.
- Conditions
- Lymphatic Insufficiency, Heart Failure, Edema
- Trial name
- LYMTRIVA (NCT04595448)
- Where
- Denmark
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
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
Tricuspid Valve Insufficiency
"Atriogenic Tricuspid Selected, Omics Profile, Multimodality Imaging and Clinical Outcomes"
The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling…
- Trial name
- ATOMIC (NCT05724225)
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Functional Tricuspid Regurgitation, Heart Valve Diseases
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with…
- Conditions
- Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
- Trial name
- NCT03632967
- Testing
- Tricinch Coil System Implantation
- Where
- 9 sites in United States
- Volunteers
- 7 people
- Sponsor
- 4Tech Cardio Ltd.
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
Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation
Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.
- Trial name
- RESERVE (NCT04141683)
- Testing
- Stress Echocardiography, Pressure volume loop analysis, Tricuspid valve repair or replacement
- Where
- Germany
- Volunteers
- 108 people
- Sponsor
- Heart Center Leipzig - University Hospital
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
Tricuspid Regurgitation
Edwards CLASP TR EFS
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
- Trial name
- CLASP TR EFS (NCT03745313)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 15 sites in United States
- Volunteers
- 65 people
- Sponsor
- Edwards Lifesciences
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, 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
- 12 sites in United States, Germany
- Volunteers
- 15 people
- Sponsor
- Innoventric LTD
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
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
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 Regurgitation
Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation
Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We…
- Trial name
- NCT01203137
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Seoul National University Hospital