Clinical trials: Tricuspid Disease
Tricuspid Atresia, Heart Defects, Congenital
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II.
- Trial name
- NCT00004828
- Testing
- liothyronine I 131
- Volunteers
- 28 people
- Sponsor
- FDA Office of Orphan Products Development
Fontan Procedure, Hypoplastic Left Heart Syndrome
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- Trial name
- NCT00974025
- Testing
- Vitamin C
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention
Early Feasibility Study of 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention
Prospective, single center, early feasibility study designed to evaluate the initial safety and device performance of the Medtronic 3830 Lead when implanted via the Middle Cardiac Vein in patients with prior or planned tricuspid…
- Trial name
- MCV3830 (NCT07805525)
- Testing
- Pacemaker
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Minneapolis Heart Institute Foundation
Valve Disease, Heart
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)
A retrospective and prospective, observational, multicenter cohort study of consecutive patients undergoing transcatheter mitral/tricuspid ViV or ViR procedure with balloon expandable valve across participating sites in…
- Trial name
- NCT07058935
- Where
- 8 sites in Australia, Hong Kong and 4 more
- Volunteers
- 150 people
- Sponsor
- National Heart Centre Singapore
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
Tricuspid Valve Regurgitation, Heart Valve Disease
The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- Trial name
- TRICURE EU (NCT06581471)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 80 people
- Sponsor
- TRiCares
Aortic Insufficiency, Aortic Stenosis
Automated Phonocardiography Analysis in Adults
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers…
- Conditions
- Aortic Insufficiency, Aortic Stenosis, Mitral Insufficiency, Mitral Insufficiency and Aortic Stenosis
- Trial name
- NCT03600051
- Testing
- Automated Heart Murmur Detection AI
- Where
- Austria
- Volunteers
- 90 people
- Sponsor
- CSD Labs GmbH
Tricuspid Regurgitation, Tricuspid Valve Disease
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- Trial name
- VISTA (NCT05797519)
- Testing
- VDyne Transcatheter Tricuspid Valve Replacement System
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 120 people
- Sponsor
- VDyne, Inc.
Coronary Artery Bypass Grafting, Heart Diseases
The Short Form-36: Pre- Versus Post-Surgical Administration in Cardiac Surgery Patients
The purpose of this study is to determine whether the SF-36 can be administered reliably to cardiac surgery patients (two to three days) post-surgery, with the patient answering the questions of this survey from a pre-surgical…
- Conditions
- Coronary Artery Bypass Grafting, Heart Diseases, Heart Valve Diseases
- Trial name
- NCT00226265
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Weill Medical College of Cornell University
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk…
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- Trial name
- CLASP II TR (NCT04097145)
- Testing
- Edwards PASCAL System, Optimal Medical Therapy
- Where
- 79 sites in United States, Canada
- Volunteers
- 1,270 people
- Sponsor
- Edwards Lifesciences
Valvular Heart Disease, Mitral Valve Disease
Prevalence Study of Cardiovascular Diseases in a Population ≥ 65 Years in Italy
This registry is a large-scale epidemiological study (PREVASC) aimed at estimating the prevalence of symptomatic and asymptomatic valvular hear disease in men and women aged over 65 years randomly selected in Italy.
- Conditions
- Valvular Heart Disease, Mitral Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency
- Trial name
- PREVASC (NCT05892588)
- Where
- Italy
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Tricuspid Valve Insufficiency
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates.
- Trial name
- NCT04522154
- Testing
- Magnet resonance imaging
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Atrial Flutter
Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter
The investigators propose a third hypothesis based on the anatomic observations made in pathological studies. The investigators hypothesize that the anatomic architecture determines the functional properties of the TV-IVC…
- Trial name
- NCT01113788
- Testing
- tricuspid isthmus imaging with Cartosound
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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.
Tricuspid Valve Regurgitation
TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years.
- Trial name
- TriBEL (NCT05577078)
- Testing
- Transcatheter edge-to-edge repair (TEER)
- Volunteers
- 120 people
- Sponsor
- AZ Sint-Jan AV
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
Cardiac Valve Disease, Aortic Valve Disease
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time.
- Conditions
- Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease
- Trial name
- NCT06001489
- Testing
- 360-degree Virtual Reality Patient Tour, State Trait Anxiety Inventory, Amsterdam Preoperative Anxiety and Information Scale
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Tricuspid Valve Insufficiency
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed.
- Trial name
- NCT01532921
- Testing
- Tricuspid valve repair, Left-sided heart surgery, Contour 3D Tricuspid Annuloplasty Ring
- Where
- 7 sites in France, Germany and 1 more
- Volunteers
- 85 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement
Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- Trial name
- NCT07691307
- Testing
- TruGamma System, Optimal medical therapy (OMT)
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Trulive Medical Co., Ltd
Tricuspid Regurgitation
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation. It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and…
- Trial name
- PREVENT (NCT02098200)
- Testing
- TriCinch System
- Where
- 14 sites in France, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- 4Tech Cardio Ltd.