Clinical trials: Tricuspid Regurgitation (TR)
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
Functional Tricuspid Regurgitation (TR)
First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation
The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein.
- Trial name
- NCT03700918
- Testing
- DaVingiTR System
- Where
- 5 sites in Czechia, France and 1 more
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC
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 (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
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical…
- Trial name
- TRILUMINATE (NCT03227757)
- Testing
- Tricuspid Valve Repair System
- Where
- 20 sites in United States, France and 4 more
- Volunteers
- 98 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation
Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage.
- Trial name
- NCT04339192
- Testing
- Minimally Invasive Tricuspid Surgery
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Shanghai Zhongshan Hospital
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
- Trial name
- NCT06212193
- Testing
- Trillium™
- Where
- 12 sites in United States, Germany
- Volunteers
- 15 people
- Sponsor
- Innoventric LTD
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 Functional, Tricuspid Regurgitation (TR)
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR), Tricuspid Regurgitation
- Trial name
- NCT07140562
- Testing
- Tricuspid Annular Therapy System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- Tangent Cardiovascular 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.
Tricuspid Regurgitation
Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million…
- Trial name
- TRIGISTRY (NCT05825898)
- Testing
- Surgery or Transcatheter tricuspid valve intervention
- Where
- 44 sites in United States, Austria and 8 more
- Volunteers
- 3,500 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Tricuspid Regurgitation (TR), Valvular Heart Diseases
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide.
- Conditions
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- Trial name
- Robotic Lux (NCT07516145)
- Testing
- Transcatheter tricuspid valve replacement
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
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
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
AV Block Complete, Tricuspid Regurgitation (TR)
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear.
- Trial name
- NCT06814574
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Tricuspid Regurgitation (TR)
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved…
- Trial name
- TREAT TR (NCT07586995)
- Testing
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation
TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System
This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation.
- Trial name
- NCT07334691
- Testing
- Cardiovalve TR valve replacement System
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Cardiovalve Ltd.
Severe Tricuspid Valve Regurgitation (Disorder)
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).
- Trial name
- NCT05045079
- Testing
- Inferior Vena Caval (IVC) Occlusion maneuver
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Mayo Clinic
Tricuspid Valve Insufficiency, Sick Sinus Syndrome
Left Ventricular Pacing to Prevent Iatrogenic TR Pilot Study
Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex.
- Trial name
- NCT02314897
- Testing
- LV pacing, RV pacing
- Where
- Singapore
- Volunteers
- 20 people
- Sponsor
- National University Hospital, Singapore
Tricuspid Regurgitation
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation
Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.
- Trial name
- NCT01502462
- Where
- South Korea
- Volunteers
- 131 people
- Sponsor
- Asan Medical Center