Clinical trials: Tricuspid Valve Disease
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
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
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.
Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart…
- Conditions
- Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT02675244
- Testing
- TV Annuloplasty, MVS
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 401 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Ebstein Anomaly, Tricuspid Valve Dysplasia
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry
Ebstein anomaly and tricuspid valve dysplasia (EA/TVD) are rare congenital tricuspid valve malformations that carry among the highest mortality of all congenital heart disease diagnosed in utero.
- Trial name
- FEAT Registry (NCT05225311)
- Testing
- Observation
- Where
- Canada
- Volunteers
- 1,500 people
- Sponsor
- The Hospital for Sick Children
Tricuspid Regurgitation (TR)
Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an…
- Trial name
- NCT06877520
- Testing
- Pivot Extend Tricuspid Regurgitation Spacer Device
- Where
- 3 sites in Georgia
- Volunteers
- 7 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Coronary Artery Bypass Grafting, Heart Diseases
The Short Form-36: Pre- Versus Post-Surgical Administration in Cardiac Surgery Patients
The purpose of this study is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical…
- Conditions
- Coronary Artery Bypass Grafting, Heart Diseases, Heart Valve Diseases
- Trial name
- NCT00226265
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Weill Medical College of Cornell University
Tricuspid Regurgitation, Heart Failure
ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
The goal of this observational study is to characterize the population of patients qualified for transcatheter tricuspid valve interventions (TTVI).
- Conditions
- Tricuspid Regurgitation, Heart Failure, Valve Heart Disease
- Trial name
- CAPTURE (NCT06838611)
- Testing
- Transcatheter edge-to-edge repair
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- Medical University of Warsaw
Tricuspid Regurgitation
TriClip CED RWE Study
This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair…
- Trial name
- TRICARE (NCT06920745)
- Testing
- The TriClip System
- Where
- United States
- Volunteers
- 2,200 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation, Mitral Regurgitation
Concomitant Tricuspid Repair in Patients With Left Heart Surgery
Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant…
- Conditions
- Tricuspid Regurgitation, Mitral Regurgitation, Cardiopulmonary Bypass
- Trial name
- NCT05595187
- Testing
- Tricuspid repair
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Nanjing Medical University
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 Insufficiency
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened.
- Trial name
- RIGHT (NCT03278418)
- Testing
- Tricuspid Valve Repair, Left-sided valve surgery
- Where
- 4 sites in Italy
- Volunteers
- 280 people
- Sponsor
- Ettore Sansavini Health Science Foundation
Functional Tricuspid Regurgitation
Outcome of MC3 Ring Annuloplasty for Functional Tricuspid Regurgitation
This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease.
- Trial name
- NCT04078867
- Testing
- tricuspid valve repair
- Volunteers
- 105 people
- Sponsor
- Minia University
Tricuspid Regurgitation, Right Ventricular Dilatation
Pharmacological Reduction of Right Ventricular Enlargement
Functional tricuspid regurgitation (TR) has been regarded as a secondary phenomenon of heart failure (HF), mitral valve (MV) disease or atrial fibrillation.
- Trial name
- PROVE (NCT04345796)
- Testing
- Carvedilol+Empagliflozin, Carvedilol, Empagliflozin
- Where
- 3 sites in South Korea
- Volunteers
- 56 people
- Sponsor
- Asan Medical Center
Cardiac Pacing, Artificial, Tricuspid Valve Regurgitation, Non-rheumatic
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic…
- Trial name
- CIED-REMTRIC (NCT06914570)
- Where
- Italy
- Volunteers
- 350 people
- Sponsor
- Istituto Auxologico Italiano
HLH - Hypoplastic Left Heart Syndrome, DORV
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
- Conditions
- HLH - Hypoplastic Left Heart Syndrome, DORV, DILV - Double Inlet Left Ventricle, Mitral Atresia
- Trial name
- TEVG-2 (NCT04467671)
- Testing
- Tissue Engineered Vascular Grafts
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Nationwide Children's Hospital
Tricuspid Regurgitation
TTVR STRONG Under Coverage With Evidence Development (CED) Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the…
- Trial name
- STRONG (NCT06833476)
- Testing
- EVOQUE
- Where
- United States
- Volunteers
- 2,044 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.
- Trial name
- BvsRR (NCT03144024)
- Testing
- band implantation, rigid ring implantation
- Where
- Russia
- Volunteers
- 308 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Functional Tricuspid Regurgitation
Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation
Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.
- Trial name
- RESERVE (NCT04141683)
- Testing
- Stress Echocardiography, Pressure volume loop analysis, Tricuspid valve repair or replacement
- Where
- Germany
- Volunteers
- 108 people
- Sponsor
- Heart Center Leipzig - University 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