Clinical trials: Severe Tricuspid Valve Regurgitation
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
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
Severe Tricuspid Regurgitation
TRICUS STUDY Euro - 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
- NCT04141137
- Testing
- TricValve® System
- Where
- 10 sites in Austria, Spain
- Volunteers
- 35 people
- Sponsor
- P+F Products + Features GmbH
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 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
Functional Tricuspid Regurgitation
Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation
This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.
- Trial name
- TRuE (NCT04173091)
- Testing
- No Intervention
- Where
- 5 sites in Germany, Israel
- Volunteers
- 2,000 people
- Sponsor
- Charite University, Berlin, Germany
Congestive Heart Failure, Tricuspid Regurgitation
Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation.
- Trial name
- HERACLES-HFpEF (NCT04782908)
- Testing
- Transcatheter tricuspid valve edge-to-edge repair
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Heart Center Leipzig - University Hospital
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 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
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.
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
Heart Valve Diseases, Aortic Valve Stenosis
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique…
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic
- Trial name
- CORONATE (NCT05714293)
- Testing
- CT scan with contrast medium
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Valve Regurgitation
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
- Trial name
- bRIGHT (NCT04483089)
- Testing
- Transcatheter heart valve procedure
- Where
- 25 sites in Austria, Denmark and 6 more
- Volunteers
- 511 people
- Sponsor
- Abbott Medical Devices
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
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
Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation
Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We…
- Trial name
- NCT01203137
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Seoul National University Hospital
Severe Tricuspid Valve Regurgitation
Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation
International Registry to collect patients with severe TR undergoing TricValve implantation from multiple Italian and European centers, aimed at: Assessing the effect of TricValve implantation on cardiovascular and all-cause…
- Trial name
- CRITICAL (NCT05820516)
- Testing
- TricValve implantation
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana