Clinical trials: Tricuspid Valve Disease
Tricuspid Regurgitation
Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension.
- Trial name
- NCT05721417
- Testing
- Tricuspid valve surgery
- Where
- Italy
- Volunteers
- 172 people
- Sponsor
- Michele De Bonis
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
Band Versus Ring for Tricuspid Regurgitation
Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly.
- Trial name
- NCT04093297
- Testing
- Tricuspid Annuloplasty
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Nanjing Medical University
Aortic Stenosis
Role of Elastin Metabolites in Aortic Remodelling in AS
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age.
- Trial name
- ELASTIC-AS (NCT03883490)
- Testing
- ECG, Blood test and biobanking, Trans-thoracic Echocardiogram
- Where
- United Kingdom
- Volunteers
- 46 people
- Sponsor
- University of Leicester
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
Heart Valve Diseases, Heart Diseases
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical…
- Conditions
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Disease
- Trial name
- TRIBLAZE (NCT07684313)
- Testing
- Edwards TRIFORMIS RESILIA heart valve
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Defect, Single-ventricle
NIRS in Congenital Heart Defects - Correlation With Echocardiography
Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow.
- Conditions
- Congenital Heart Defect, Single-ventricle, Coarctation of Aorta, Atrioventricular Canal
- Trial name
- NCT04106479
- Testing
- NIRS evaluation
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Severe Tricuspid Regurgitation
International Multisite Transcatheter Tricuspid Valve Therapies Registry
For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with…
- Trial name
- TriValve (NCT03416166)
- Testing
- Transcatheter Tricuspid Intervention
- Where
- Switzerland
- Volunteers
- 269 people
- Sponsor
- University of Zurich
Tricuspid Regurgitation
SQ-Kyrin-T First-in-man Feasibility Study
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with…
- Trial name
- NCT06605313
- Testing
- SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
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 Valve Regurgitation, Tricuspid Valve Insufficiency
TRISCEND II Pivotal Trial
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- NCT04482062
- Testing
- Edwards EVOQUE System, Optimal Medical Therapy
- Where
- 62 sites in United States, Germany
- Volunteers
- 864 people
- Sponsor
- Edwards Lifesciences
Heart Valvular Disease
Multi-center Research Clinical Trial Protocol for Etiology-pathology and Repair Classification of Mitral and Tricuspid Valves
The choice of valve repair is very important in the treatment of cardiac valve disease, and its core is the etiology pathology analysis, which directly determines the design of repair strategy and the quality of postoperative…
- Trial name
- NCT07863531
- Testing
- Valve repair, Valve replacement
- Volunteers
- 200 people
- Sponsor
- Keli Huang
Tricuspid Regurgitation
Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).
- Trial name
- NCT05006443
- Testing
- Cardiac Magnetic Resonance
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Mayo Clinic
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
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
Tricuspid Valve Regurgitation, Heart Valve Diseases
The TRICURE EFS Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRICURE EFS (NCT06506942)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 10 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- TRiCares
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
Heart Failure, Valvulopathy
Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)
This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients…
- Conditions
- Heart Failure, Valvulopathy, Aortic Stenosis, Aortic Regurgitation Disease
- Trial name
- OPTIMAV (NCT06667128)
- Testing
- Rapid Uptitration of Guideline-Directed Medical Therapy, Elecsys® NT-proBNP - Roche Diagnostics, Rapid Up-Titration GDMT Group with Hospital Monitoring
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- IRCCS Ospedale San Raffaele
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
Structural Heart Disease, Mitral Valve Regurgitation
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry
A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves.
- Trial name
- AP ViV (NCT07296016)
- Where
- Hong Kong
- Volunteers
- 15 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong