Clinical trials: Tricuspid Valve Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
EFS of the DUO System for Tricuspid Regurgitation
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- TANDEM II (NCT05913908)
- Testing
- DUO Transcatheter Tricuspid Coaptation Valve System
- Where
- 18 sites in United States, Poland
- Volunteers
- 15 people
- Sponsor
- CroiValve Limited
Allografts, Tricuspid Valve Insufficiency
Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.
- Trial name
- ESEMATS (NCT06196684)
- Testing
- Mitral allograft implantation
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Chelyabinsk Regional Clinical Hospital
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.
Tricuspid Regurgitation, Heart Failure
Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to…
- Trial name
- NCT04570098
- Where
- Germany
- Volunteers
- 1,016 people
- Sponsor
- Charite University, Berlin, Germany
Tricuspid Regurgitation
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation. It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and…
- Trial name
- PREVENT (NCT02098200)
- Testing
- TriCinch System
- Where
- 14 sites in France, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- 4Tech Cardio Ltd.
Tricuspid Regurgitation, Heart Failure
ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
The goal of this observational study is to characterize the population of patients qualified for transcatheter tricuspid valve interventions (TTVI).
- Conditions
- Tricuspid Regurgitation, Heart Failure, Valve Heart Disease
- Trial name
- CAPTURE (NCT06838611)
- Testing
- Transcatheter edge-to-edge repair
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- Medical University of Warsaw
Defibrillator, Tricuspid Valve Regurgitation
Early Feasibility Study of 3930M Defibrillation Lead Implantation Via the Middle Cardiac Vein in Patients With Tricuspid Valve Regurgitation
Prospective, single center, early feasibility study designed to evaluate the initial safety and device performance of the Medtronic 3930M Lead when implanted via the Middle Cardiac Vein in patients with Tricuspid Valve…
- Trial name
- MCV3930 EFS (NCT07811609)
- Testing
- Defibrillator
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Minneapolis Heart Institute Foundation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Insufficiency, Heart Failure
- Trial name
- NCT05114850
- Where
- 28 sites in Austria, Belgium and 3 more
- Volunteers
- 450 people
- Sponsor
- P+F Products + Features GmbH
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid…
- Conditions
- Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD)
- Trial name
- TRIUMPH (NCT07687485)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
- Where
- 2 sites in United States
- Volunteers
- 700 people
- Sponsor
- Laplace Interventional, Inc
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.
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 Regurgitation
Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation
The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.
- Trial name
- NCT04921605
- Testing
- DragonFly transcatheter mitral valve clamping system
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
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
Ischemic Heart Disease, Aortic Stenosis, Severe
Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass.
- Conditions
- Ischemic Heart Disease, Aortic Stenosis, Severe, Aortic Insufficiency, Mitral Stenosis
- Trial name
- NCT06377449
- Testing
- Ultrasound examination of the lungs
- Where
- Russia
- Volunteers
- 186 people
- Sponsor
- Saint Petersburg State University, Russia
Healthy Adults, Pulmonary Hypertension
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure
- Trial name
- NCT07292896
- Where
- 25 sites in China
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Tricuspid Regurgitation, Computed Tomography
CT Prediction for Transcatheter Tricuspid Interventions
The aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR).
- Trial name
- CESAR-TR (NCT06951126)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
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
Tricuspid Regurgitation
SQ-Kyrin-T First-in-man Feasibility Study
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with…
- Trial name
- NCT06605313
- Testing
- SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Tricuspid Valve Regurgitation, Heart Valve Diseases
The TRICURE EFS Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRICURE EFS (NCT06506942)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 10 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- TRiCares
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