Clinical trials: Tricuspid Valve Regurgitation
Tricuspid Valve Regurgitation, Heart Valve Disease
The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- Trial name
- TRICURE EU (NCT06581471)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 80 people
- Sponsor
- TRiCares
Tricuspid Regurgitation
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients…
- Trial name
- SPACER (NCT07172477)
- Testing
- Pivot Extend
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Tau Medical Australia Pty Ltd
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
Atrial Fibrillation (AF), Tricuspid Regurgitation (TR)
Efficacy of Early Rhythm Control in AF With TR Patients
Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes.
- Trial name
- TRAF (NCT07607093)
- Testing
- Anti-arrhythmic drugs for rhythm control, DC cardioversion, catheter ablation for rhythm control, Usual care
- Where
- South Korea
- Volunteers
- 5,800 people
- Sponsor
- Samsung Medical Center
Heart Valve Incompetence, Echocardiography, Transthoracic
The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
Prospective, multicenter, observational study to enroll consecutive patients with functional tricuspid regurgitation (FTR) with the primary aim to: Use patients' outcomes as a reference to try to define the threshold values for…
- Trial name
- FUTURE 3D (NCT05747404)
- Testing
- Echocardiography
- Where
- 4 sites in Italy, Romania
- Volunteers
- 1,500 people
- Sponsor
- Istituto Auxologico Italiano
Tricuspid Regurgitation
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery.
- Trial name
- NCT05436028
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- France
- Volunteers
- 161 people
- Sponsor
- Jenscare Scientific
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
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
Coronary Artery Disease, Coronary Artery Stenoses
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
- Trial name
- NCT03270514
- Testing
- Exparel Injectable Product, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Kathirvel Subramaniam
Tricuspid Regurgitation
Study of Transcatheter Tricuspid Annular Repair
The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.
- Trial name
- STTAR (NCT03692598)
- Testing
- MIA, Minimally Invasive Annuloplasty Device - Surgical, MIA, Minimally Invasive Annuloplasty Device - Percutaneous
- Where
- 6 sites in Denmark, Hungary and 3 more
- Volunteers
- 60 people
- Sponsor
- Micro Interventional Devices
Severe Tricuspid Regurgitation
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
- Trial name
- PATHFINDER (NCT07321899)
- Testing
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Where
- 13 sites in United States
- Volunteers
- 1,186 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Regurgitation
TRicuspid Uk STudy
This is a multicentre, randomised, placebo-controlled trial conducted at St Bartholomew's Hospital, John Radcliff Hospital, Royal Brompton Hospital, and Kings College London Hospital.
- Trial name
- TRUST (NCT07133386)
- Testing
- transcatheter edge to edge repair
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Barts & The London NHS Trust
Tricuspid Valve Regurgitation
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical…
- Trial name
- SPACER (NCT02787408)
- Testing
- EW Tricuspid Transcatheter Repair System
- Where
- 11 sites in Canada, France and 3 more
- Volunteers
- 25 people
- Sponsor
- Edwards Lifesciences
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 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
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR).
- Trial name
- NCT05836493
- Testing
- Ring annuloplasty, Suture procedure
- Where
- Italy
- Volunteers
- 146 people
- Sponsor
- Michele De Bonis
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.
Valvular Heart Disease
The Bronx-Valve Registry
The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams.
- Trial name
- NCT05453526
- Where
- United States
- Volunteers
- 330,570 people
- Sponsor
- Montefiore Medical Center
Atrial Fibrillation (AF), Tricuspid Regurgitation (TR)
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study
This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden…
- Trial name
- TRICUSPID-AF (NCT07617974)
- Where
- Italy
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Centro Cardiologico Monzino