Clinical trials: Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency
Long-term Outcome After Isolated Tricuspid Valve Repair
Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention.
- Trial name
- NCT01537458
- Testing
- follow-up of isolated tricuspid valve repair
- Where
- Belgium
- Volunteers
- 98 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
Right Heart Failure
Accelerated LBBP for Patients With RHF and Severe TR
This study is a prospective, single-arm, target value clinical trial. We plan to prospectively enroll and follow 24 patients across three centers nationwide who have a low baseline heart rate (HR ≤ 60 bpm), meet the indication…
- Trial name
- ARCP (NCT07470047)
- Testing
- permanent pacemaker implantation
- Where
- 3 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai Zhongshan Hospital
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
Tricuspid Valve Regurgitation
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and…
- Trial name
- NCT05194423
- Testing
- Tricuspid Valve Replacement System via jugular vein
- Where
- 9 sites in China
- Volunteers
- 150 people
- Sponsor
- Changhai Hospital
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
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 (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
Tricuspid Regurgitation
Band Versus Ring for Tricuspid Regurgitation
Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly.
- Trial name
- NCT04093297
- Testing
- Tricuspid Annuloplasty
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Nanjing Medical University
Murmur, Heart, Aortic Valve Stenosis
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML…
- Conditions
- Murmur, Heart, Aortic Valve Stenosis, Tricuspid Regurgitation, Mitral Regurgitation
- Trial name
- NCT04400513
- Testing
- Use of Eko CORE and Eko DUO electronic stethoscopes
- Where
- United States
- Volunteers
- 1,145 people
- Sponsor
- Eko Devices, Inc.
Severe Tricuspid Regurgitation
Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)
The purpose of this study is to assess the efficacy and safety of implanting an Edwards Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein) on clinical variables, exercise tolerance and…
- Trial name
- NCT02387697
- Testing
- Edwards Sapien XT Valve
- Where
- Germany
- Volunteers
- 28 people
- Sponsor
- Charite University, Berlin, Germany
Tricuspid Regurgitation
The TRICURE First in Human Trial
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver…
- Trial name
- TRICURE (NCT05126030)
- Testing
- Topaz TTVR System
- Where
- 11 sites in Belgium, France
- Volunteers
- 20 people
- Sponsor
- TRiCares
Tricuspid Regurgitation
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled.
- Trial name
- NCT04289870
- Testing
- Trillium™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Innoventric LTD
Tricuspid Regurgitation (TR)
TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)
The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment.
- Trial name
- NCT06568003
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Jenscare Innovation Inc.
Tricuspid Valve Insufficiency, Right Heart Failure
Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation.
- Conditions
- Tricuspid Valve Insufficiency, Right Heart Failure, Heart Failure
- Trial name
- TVVAD (NCT03775759)
- Testing
- Tricuspid valve repair or replacement, Medical management of tricuspid regurgitation
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Duke University
Tricuspid Regurgitation
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate…
- Trial name
- NCT05556460
- Testing
- DragonFly-T Transcatheter Tricuspid Valve Repair System, Medical therapy
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
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
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
Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation
To evaluate the safety and effectiveness of Dawneo Neoblazar® transcatheter tricuspid valve edge-to-edge repair system in patients with severe tricuspid regurgitation.
- Trial name
- NCT05497141
- Testing
- Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
Bradycardia
Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker
Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site
- Trial name
- MICRA-SYNK (NCT05817695)
- Testing
- Leadless pacemaker
- Where
- China
- Volunteers
- 40 people
- Sponsor
- First People's Hospital of Hangzhou