Clinical trials: Tricuspid Valve Disease
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
Aortic Valve Disease
Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases
Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients.
- Trial name
- NCT04816851
- Testing
- OZAKI technique
- Where
- Egypt
- Volunteers
- 1 people
- Sponsor
- Assiut University
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 Valve Insufficiency
Transcatheter Interventions for Tricuspid Insufficiency in Italy
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment.
- Trial name
- TRIC-IT (NCT04735003)
- Testing
- Transcatheter tricuspid valve interventions
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Marianna Adamo
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
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
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
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
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
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Tricuspid Valve Regurgitation, Nonrheumatic, Cardiac Catheterization
Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation
This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC…
- Conditions
- Tricuspid Valve Regurgitation, Nonrheumatic, Cardiac Catheterization, Heart Failure, Right Sided, Valve Regurgitation, Tricuspid
- Trial name
- TRACE-NL (NCT05628779)
- Testing
- TriClip TTVr system (Abbott Vascular), PASCAL TTVr system (Edwards Lifesciences)
- Where
- 6 sites in Netherlands
- Volunteers
- 150 people
- Sponsor
- St. Antonius 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, 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
Carcinoid Heart Disease, Neuroendocrine Tumors
CardioNETPOL National Registry of Carcinoid Heart Disease
Carcinoid tumors are neuroendocrine tumors (NETs), most commonly originating from the gastrointestinal tract, that may secrete bioactive substances such as serotonin.
- Conditions
- Carcinoid Heart Disease, Neuroendocrine Tumors, Carcinoid Syndrome, Valvular Heart Disease Patients
- Trial name
- CardioNETPOL (NCT07450287)
- Testing
- Observational Registry of Carcinoid Heart Disease
- Where
- Poland
- Volunteers
- 120 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Tricuspid Regurgitation, Pacemaker Complication
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only.
- Trial name
- PLACE (NCT05667519)
- Testing
- Additional guidance of lead implantation by transesophageal echocardiography
- Where
- Germany
- Volunteers
- 324 people
- Sponsor
- LMU Klinikum
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.
Defibrillator, Tricuspid Valve Regurgitation
Early Feasibility Study of 3930M Defibrillation Lead Implantation Via the Middle Cardiac Vein in Patients With Tricuspid Valve Regurgitation
Prospective, single center, early feasibility study designed to evaluate the initial safety and device performance of the Medtronic 3930M Lead when implanted via the Middle Cardiac Vein in patients with Tricuspid Valve…
- Trial name
- MCV3930 EFS (NCT07811609)
- Testing
- Defibrillator
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Minneapolis Heart Institute Foundation
Tricuspid Regurgitation, Heart Valve Diseases
The CLASP III TR 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 Repair procedure using the…
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT07859709
- Testing
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- Edwards Lifesciences
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
SGLT2 Inhibitor for Severe Tricuspid Regurgitation
The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated…
- Trial name
- Reduction-TR (NCT05686616)
- Testing
- Dapagliflozin Propanediol Hydrate 12.3 mg
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- Samsung Medical Center