Clinical trials: Functional Tricuspid Regurgitation
Tricuspid (Valve) Insufficiency (Rheumatic)
PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be…
- Trial name
- PROCIDA (NCT03129737)
- Testing
- Mitral valve surgery, Tricuspid valve annuloplasty
- Where
- 8 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Ettore Sansavini Health Science Foundation
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid…
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT-II (NCT03225612)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in Germany, Italy and 2 more
- Volunteers
- 60 people
- Sponsor
- Mitralign, Inc.
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
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 (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
Mitral Regurgitation, Mitral Stenosis
Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery
The 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
- NCT06664320
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- 2 sites in South Korea
- Volunteers
- 70 people
- Sponsor
- Konkuk University Medical Center
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
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.
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
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
- Trial name
- NCT05854095
- Testing
- Pivot Bridge
- Where
- 10 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
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 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
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
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
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
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 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, 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.
Atrial Fibrillation, Functional Mitral Regurgitation
Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation
A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation.
- Conditions
- Atrial Fibrillation, Functional Mitral Regurgitation, Functional Tricuspid Regurgitation
- Trial name
- NCT05920824
- Testing
- Echocardiogram
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Barts & The London NHS Trust
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