Clinical trials: Tricuspid Insufficiency
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 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, Tricuspid Valve Insufficiency
German Registry for Transcatheter Tricuspid Valve Interventions
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve
- Trial name
- NCT04653428
- Testing
- Interventional treatment of tricuspid regurgitation
- Where
- Germany
- Volunteers
- 600 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
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
Tricuspid Regurgitation
Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation
The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.
- Trial name
- NCT04921605
- Testing
- DragonFly transcatheter mitral valve clamping system
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Tricuspid Regurgitation, Tricuspid Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
- Trial name
- TriBAND (NCT03779490)
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Stenosis
Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT02831270
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Konkuk University Medical Center
Degeneration of Tricuspid Surgical Bioprosthesis
Influence of Original Native Tricuspid Valve Lesion (Stenosis or Steno-insufficiency or Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Tricuspid Valve Replacement.
The structural deterioration process of the implanted bioprosthesis in tricuspid position for tricuspid valve pathology is gradual and irreversible and includes many changes, such as pannus growth, leaflet fibrosis and…
- Trial name
- DURABLE-TRIC (NCT06875154)
- Testing
- Valve replacement
- Where
- Netherlands
- Volunteers
- 500 people
- Sponsor
- Maastricht University Medical Center
Tricuspid Regurgitation (TR)
The TRICURE US IDE Pivotal Study
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
- Trial name
- TRICURE US IDE (NCT07528326)
- Testing
- TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System
- Where
- United States
- Volunteers
- 831 people
- Sponsor
- TRiCares
Tricuspid Valve Insufficiency
Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
Right-sided heart disease has an important impact on the prognosis of patients with valvular heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics have not been extensively investigated.
- Trial name
- NCT01444222
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Tricuspid Regurgitation
Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography
This study is a prospective observational chart review. The aim of the study is to evaluate tricuspid regurgitation volume using 3D volumetric assessment as an accurate method for tricuspid regurgitation severity in comparison to…
- Trial name
- NCT05130775
- Testing
- Transesophageal echocardiograpgy
- Where
- United States
- Sponsor
- Tufts Medical Center
Tricuspid Regurgitation
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd.
- Trial name
- NCT05434507
- Testing
- Transcatheter Annuloplasty
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai Huihe Medical Technology Co., Ltd
Functional Tricuspid Regurgitation, Heart Valve Diseases
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with…
- Conditions
- Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
- Trial name
- NCT03632967
- Testing
- Tricinch Coil System Implantation
- Where
- 9 sites in United States
- Volunteers
- 7 people
- Sponsor
- 4Tech Cardio Ltd.
Tricuspid Regurgitation
The TRICURE First in Human Trial
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver…
- Trial name
- TRICURE (NCT05126030)
- Testing
- Topaz TTVR System
- Where
- 11 sites in Belgium, France
- Volunteers
- 20 people
- Sponsor
- TRiCares
Systemic Right Ventricle, Tricuspid Regurgitation
Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort (PETER-TRESRIV)
Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve…
- Conditions
- Systemic Right Ventricle, Tricuspid Regurgitation, Congenital Heart Disease
- Trial name
- PETER-TRESRIV (NCT05052177)
- Testing
- Edge to edge repair in systemic tricuspid valve regurgitation
- Where
- France
- Volunteers
- 10 people
- Sponsor
- University of Bordeaux
Heart Valve Incompetence, Atrial Fibrillation, Persistent
In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation
1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography.
- Trial name
- ASTRA (NCT05749107)
- Testing
- Echocardiography, Proteomic analyses
- Where
- 2 sites in Italy
- Volunteers
- 1,050 people
- Sponsor
- Istituto Auxologico Italiano
Mitral Valve Regurgitation, Mitral Valve Stenosis
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation
- Trial name
- OBSERV-MITRA (NCT04577248)
- Testing
- edge-to-edge valve repair
- Where
- Germany
- Volunteers
- 5,000 people
- Sponsor
- Deutsches Herzzentrum Muenchen