Clinical trials: Tricuspid Regurgitation
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.
Mitral Regurgitation, Mitral Stenosis
Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery
The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT06664320
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- 2 sites in South Korea
- Volunteers
- 70 people
- Sponsor
- Konkuk University Medical Center
Tricuspid Regurgitation, Right Heart Failure
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients.
- Conditions
- Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular, Cardiac Remodeling, Atrial
- Trial name
- NCT05179616
- Testing
- Transcatheter edge-to-edge tricuspid valve repair
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Helios Klinikum Pforzheim
Tricuspid Regurgitation
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation.
- Trial name
- NCT03294200
- Testing
- TriCinch Coil System implantation
- Where
- 13 sites in Australia, Belgium and 5 more
- Volunteers
- 18 people
- Sponsor
- 4Tech Cardio Ltd.
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
Tricuspid Regurgitation
Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results
Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure .
- Trial name
- NCT05774821
- Testing
- Tricuspid valve surgery
- Where
- Italy
- Volunteers
- 151 people
- Sponsor
- Michele De Bonis
Tricuspid Regurgitation
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
- Trial name
- NCT06183684
- Testing
- Laplace TTVR System
- Where
- 10 sites in United States
- Volunteers
- 65 people
- Sponsor
- Laplace Interventional, Inc
Tricuspid Regurgitation
TRILUMINATE Pivotal Trial
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or…
- Trial name
- NCT03904147
- Testing
- TriClipTM Device
- Where
- 76 sites in United States, Canada and 3 more
- Volunteers
- 572 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Insufficiency
Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome.
- Trial name
- NCT01580436
- Testing
- Tricuspid Valve Annuloplasty
- Where
- Belgium
- Volunteers
- 300 people
- Sponsor
- Hasselt University
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
Aortic Stenosis, Mitral Regurgitation
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- MASTER-TAVI II (NCT07623083)
- Volunteers
- 300 people
- Sponsor
- Josep Rodes-Cabau
Atrial Fibrillation (AF), Mitral Regurgitation
The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation
Atrial fibrillation (AF) is the most common cardiac arrhythmia in the clinic and can lead to valve regurgitation and a poor prognosis.
- Conditions
- Atrial Fibrillation (AF), Mitral Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT07085650
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- First Hospital of China Medical University
Mitral Regurgitation, Mitral Stenosis
Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT02502448
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Konkuk University Medical Center
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, 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, 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
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
Heart Failure Attributable to Severe Tricuspid Regurgitation
TRICuspid Intervention in Heart Failure Trial
Aims: Tricuspid regurgitation (TR) is a detrimental disease frequently diagnosed in patients with right-sided heart failure (HF).
- Trial name
- TRIC-I-HF (NCT04634266)
- Testing
- Transcatheter tricuspid valve treatment (TTVT)
- Where
- 28 sites in Germany
- Volunteers
- 360 people
- Sponsor
- LMU Klinikum
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
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