Clinical trials: Tricuspid Insufficiency
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
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), 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), Tricuspid Regurgitation (TR)
Efficacy of Early Rhythm Control in AF With TR Patients
Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes.
- Trial name
- TRAF (NCT07607093)
- Testing
- Anti-arrhythmic drugs for rhythm control, DC cardioversion, catheter ablation for rhythm control, Usual care
- Where
- South Korea
- Volunteers
- 5,800 people
- Sponsor
- Samsung Medical Center
Aortic Stenosis, Aortic Regurgitation
Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease
This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT07605624
- Testing
- Transcatheter Aortic Valve Replacement, Transcatheter Edge-to-Edge Repair, Transcatheter Tricuspid Valve Annuloplasty
- Where
- China
- Volunteers
- 5,500 people
- Sponsor
- Beijing Anzhen Hospital
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
Mitral Regurgitation, Tricuspid Regurgitation
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation.
- Conditions
- Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
- Trial name
- ARB-PMCF (NCT04761120)
- Testing
- Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring, Abbott SJM Tailor Ring
- Where
- 17 sites in United States, Estonia and 5 more
- Volunteers
- 550 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Regurgitation
Clinical Study of the inQB8 TTVR System (The MonarQ Study)
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
- Trial name
- NCT06611579
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in United States, Belgium and 1 more
- Volunteers
- 50 people
- Sponsor
- inQB8 Medical Technologies, LLC
Tricuspid Insufficiency, Tricuspid Regurgitation (TR)
PASCAL Precision-GDMT Registry
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be…
- Conditions
- Tricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction, Left Ventricular (LV) Systolic Dysfunction
- Trial name
- PASCAL (NCT07578129)
- Volunteers
- 50 people
- Sponsor
- Ceric Sàrl
Tricuspid Regurgitation
Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement.
- Trial name
- NCT04100720
- Testing
- Cardiovalve Transfemoral Tricuspid Valve
- Where
- 3 sites in United States
- Sponsor
- Cardiovalve Ltd.
Tricuspid Regurgitation
TARGET Study: Safety and Performance of the Cardiovalve TR Replacement System
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
- Trial name
- TARGET (NCT05486832)
- Testing
- Cardiovalve TR valve replacement System
- Where
- 7 sites in Germany
- Volunteers
- 157 people
- Sponsor
- Cardiovalve Ltd.
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
Tricuspid Regurgitation
TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System
This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation.
- Trial name
- NCT07334691
- Testing
- Cardiovalve TR valve replacement System
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Cardiovalve Ltd.
Tricuspid Regurgitation
Clinical Study of Edwards Cardioband FIT Valve Repair System
Clinical Study of the Edwards Cardioband FIT Repair System
- Trial name
- NCT03382457
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Edwards Lifesciences
Tricuspid Valve Regurgitation, Heart Valve Diseases
2019-06 TRISCEND Study
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT04221490
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 228 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation, Tricuspid Valve Disease
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
The purpose of this investigation is to see if the TRICENTO Valved Stent Graft implant reduces tricuspid regurgitation (TR) and improves the symptoms and quality of life in 15 participants with carcinoid heart disease, and who…
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Carcinoid Syndrome, Carcinoid Heart Disease
- Trial name
- TRICAR (NCT05064514)
- Testing
- Transcatheter Tricuspid Valved Stent Graft
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Queen Mary University of London
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
Heart Failure With Severe Tricuspid Regurgitation
TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure
Tricuspid regurgitation (TR) is a severe and highly prevalent disease that leads to right-sided heart failure. The severity of TR is associated with increasing morbidity and mortality.
- Trial name
- TRIC-I-HF 2 (NCT07442903)
- Testing
- Pulmonary artery sensor system
- Where
- 2 sites in Germany
- Volunteers
- 45 people
- Sponsor
- LMU Klinikum
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
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