Clinical trials: Tricuspid Disease
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 Insufficiency
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical…
- Trial name
- TRILUMINATE (NCT03227757)
- Testing
- Tricuspid Valve Repair System
- Where
- 20 sites in United States, France and 4 more
- Volunteers
- 98 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Regurgitation
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical…
- Trial name
- SPACER (NCT02787408)
- Testing
- EW Tricuspid Transcatheter Repair System
- Where
- 11 sites in Canada, France and 3 more
- Volunteers
- 25 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
Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)
The goal of this study is to determine the short term safety (<30 days) and efficacy (6 months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe tricuspid…
- Trial name
- HOVER (NCT02339974)
- Testing
- Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Henry Ford Health System
Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart…
- Conditions
- Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT02675244
- Testing
- TV Annuloplasty, MVS
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 401 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Tricuspid Valve Regurgitation
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and…
- Trial name
- NCT02471807
- Testing
- Edwards FORMA Tricuspid Transcatheter Repair System
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Edwards Lifesciences
Sickle Cell Disease, Pulmonary Hypertension
Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease
This study will examine whether the drug sildenafil can lower blood pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) in patients with sickle cell disease and pulmonary hypertension (high…
- Trial name
- NCT00492531
- Testing
- Sildenafil
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 74 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Tricuspid Valve Insufficiency, Tricuspid Regurgitation
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement.
- Conditions
- Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases
- Trial name
- TRI-REPAIR (NCT02981953)
- Testing
- Cardioband Tricuspid
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 40 people
- Sponsor
- Edwards Lifesciences
Paroxysmal Atrial Fibrillation
The FARAPULSE FARA-Freedom Trial
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed…
- Trial name
- FARA-Freedom (NCT05072964)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 13 sites in Belgium, Czechia and 4 more
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Dilated Cardiomyopathy, Tricuspid Atresia
Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease
The aim of this project is assess a non-invasive functional liver tests in patients with the Fontan circulation that may be used for prognostic purposes.
- Trial name
- MBT+Fontan (NCT04176458)
- Testing
- Methacetin Breath Test (MBT)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Northwestern University
Coronary Artery Disease, Coronary Artery Stenoses
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
- Trial name
- NCT03270514
- Testing
- Exparel Injectable Product, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Kathirvel Subramaniam
Atrial Fibrillation, Atrial Flutter
Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus
The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter.
- Trial name
- Amigo-AFL (NCT02467179)
- Testing
- Amigo™ Robotic Catheter Manipulation, Manual Catheter Manipulation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Tricuspid Regurgitation
Edwards CLASP TR EFS
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
- Trial name
- CLASP TR EFS (NCT03745313)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 15 sites in United States
- Volunteers
- 65 people
- Sponsor
- Edwards Lifesciences
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Sildenafil After the Fontan Operation
In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation.
- Trial name
- SAFO (NCT00507819)
- Testing
- Sildenafil
- Volunteers
- 28 people
- Sponsor
- Children's Hospital of Philadelphia
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.
- Trial name
- Contour3D (NCT01585779)
- Testing
- Contour 3D® implant for tricuspid valve repair, Tri-Ad® implant for tricuspid valve repair
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Medtronic Cardiovascular
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Hypoplastic Left Heart, Tetralogy of Fallot
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication.
- Conditions
- Hypoplastic Left Heart, Tetralogy of Fallot, Tricuspid Atresia
- Trial name
- InfantDex (NCT00573066)
- Testing
- Dexmedetomidine
- Volunteers
- 56 people
- Sponsor
- Athena Zuppa