Clinical trials: Tricuspid Valve Insufficiency
Tricuspid Regurgitation
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the…
- Trial name
- TRIPLACE (NCT06033274)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 31 sites in United States, Canada and 6 more
- Volunteers
- 800 people
- Sponsor
- Montefiore Medical Center
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk…
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- Trial name
- CLASP II TR (NCT04097145)
- Testing
- Edwards PASCAL System, Optimal Medical Therapy
- Where
- 79 sites in United States, Canada
- Volunteers
- 1,270 people
- Sponsor
- Edwards Lifesciences
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
Valvular Heart Disease
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR).
- Trial name
- HOMERUNHITTER (NCT06077201)
- Testing
- HBCR hands-off, HBCR interactive
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Vanderbilt University Medical Center
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation, CIED Implantation
3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device
The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs).
- Conditions
- Tricuspid Regurgitation, CIED Implantation, Leadless Pacemaker, Pacemaker
- Trial name
- 3DECHO-TR (NCT07793916)
- Testing
- 3D Transthoracic echocardiographic evaluation
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
Tricuspid Regurgitation, Tricuspid Valve Disease
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve®…
- Trial name
- TRICAV-I (NCT06137807)
- Testing
- TricValve® Transcatheter Bicaval Valve System
- Where
- 36 sites in United States
- Volunteers
- 50 people
- Sponsor
- P+F Products + Features USA Inc.
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 (TR)
Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)
The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system.
- Trial name
- NCT07454980
- Testing
- TTVI with LuX-Valve Plus System, TTVI with EVOQUE
- Where
- 7 sites in United States, Canada
- Volunteers
- 680 people
- Sponsor
- Jenscare Innovation 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 Valve Regurgitation, Tricuspid Valve Disease
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases
- Trial name
- TRIVITA (NCT07516444)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
- Where
- United States
- Volunteers
- 730 people
- Sponsor
- VDyne, Inc.
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
Laplace Early Feasibility Study - Canada
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
- Trial name
- NCT07171060
- Testing
- Laplace TTVR System
- Where
- 3 sites in Canada
- Volunteers
- 15 people
- Sponsor
- Laplace Interventional, Inc
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
- Volunteers
- 700 people
- Sponsor
- Laplace Interventional, Inc
Tricuspid Valve Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid…
- Trial name
- TriCLASP (NCT04614402)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System
- Where
- 15 sites in Germany, Greece and 2 more
- Volunteers
- 300 people
- Sponsor
- Edwards Lifesciences
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
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
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement
Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- Trial name
- NCT07691307
- Testing
- TruGamma System, Optimal medical therapy (OMT)
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Trulive Medical Co., Ltd
HFrEF, Tricuspid Regurgitation (TR)
Efficacy of Verciguat in TR and RV Failure
The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function.
- Trial name
- VERT-HF (NCT07668739)
- Testing
- Vericiguat
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Daejeon St. Mary's hospital
Tricuspid Valve Disease
Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation
The tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.
- Trial name
- EPIT (NCT03546231)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens