Clinical trials: Tricuspid Valve Insufficiency
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.
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 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
Tricuspid Regurgitation (TR)
The TRICURE US IDE Pivotal Study
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
- Trial name
- TRICURE US IDE (NCT07528326)
- Testing
- TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System
- Where
- United States
- Volunteers
- 831 people
- Sponsor
- TRiCares
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Tricuspid Regurgitation, Heart Valve Diseases
The CLASP III TR CED Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the…
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT07859709
- Testing
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System
The present clinical trial is performed to evaluate the effectiveness and safety of transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Healthcare technology Co.,Ltd.
- Trial name
- TriStar (NCT05173233)
- Testing
- Transcatheter Annuloplasty
- Volunteers
- 67 people
- Sponsor
- Shanghai Huihe Medical Technology Co., Ltd
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
TRISCEND II Pivotal Trial
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- NCT04482062
- Testing
- Edwards EVOQUE System, Optimal Medical Therapy
- Where
- 62 sites in United States, Germany
- Volunteers
- 864 people
- Sponsor
- Edwards Lifesciences
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
A First in Human Study for the Versa Device for Tricuspid Regurgitation
This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical…
- Trial name
- NCT06368401
- Testing
- Versa Implant
- Where
- 5 sites in Brazil, Chile and 1 more
- Volunteers
- 10 people
- Sponsor
- Versa Vascular, Inc
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, Tricuspid Valve Disease
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- Trial name
- VISTA (NCT05797519)
- Testing
- VDyne Transcatheter Tricuspid Valve Replacement System
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 120 people
- Sponsor
- VDyne, 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, 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 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
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
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.
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
TRILUMINATE Pivotal Trial
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or…
- Trial name
- NCT03904147
- Testing
- TriClipTM Device
- Where
- 76 sites in United States, Canada and 3 more
- Volunteers
- 572 people
- Sponsor
- Abbott Medical Devices