Clinical trials: Tricuspid Valve Disease
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, Tricuspid Valve Insufficiency
Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Insufficiency, Heart Failure
- Trial name
- NCT05114850
- Where
- 28 sites in Austria, Belgium and 3 more
- Volunteers
- 450 people
- Sponsor
- P+F Products + Features GmbH
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.
Tricuspid Regurgitation
PASCAL for Tricuspid Regurgitation - a European Registry
This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in…
- Trial name
- PASTE (NCT05328284)
- Testing
- PASCAL leaflet repair system
- Where
- 14 sites in Germany, Sweden and 1 more
- Volunteers
- 1,000 people
- Sponsor
- LMU Klinikum
Tricuspid Regurgitation
A First in Human Study for the Versa Device for Tricuspid Regurgitation
This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical…
- Trial name
- NCT06368401
- Testing
- Versa Implant
- Where
- 5 sites in Brazil, Chile and 1 more
- Volunteers
- 10 people
- Sponsor
- Versa Vascular, Inc
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
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
Valvular Heart Disease
The Bronx-Valve Registry
The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams.
- Trial name
- NCT05453526
- Where
- United States
- Volunteers
- 330,570 people
- Sponsor
- Montefiore Medical Center
Tricuspid Regurgitation
Laplace Early Feasibility Study - Canada
The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
- Trial name
- NCT07171060
- Testing
- Laplace TTVR System
- Where
- 3 sites in Canada
- Volunteers
- 15 people
- Sponsor
- Laplace Interventional, Inc
Tricuspid Regurgitation
Tricuspid Cardiopulmonary Exercise Study
Tricuspid regurgitation (TR), which in close to 90% of cases is functional as a consequence of left-sided heart failure, left heart valve abnormalities or pulmonary (vascular) disease, is associated with adverse patient outcomes…
- Trial name
- TRCPET (NCT04559256)
- Testing
- Cardiopulmonary Exercise Testing
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
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
Severe Tricuspid Valve Regurgitation (Disorder)
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).
- Trial name
- NCT05045079
- Testing
- Inferior Vena Caval (IVC) Occlusion maneuver
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Mayo Clinic
Tricuspid Valve Regurgitation
MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- NCT04073979
- Testing
- Mistral implantation
- Where
- 4 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Mitralix
Aortic Valve Disease
A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
For this study, blood and tissue samples will be collected in order to perform genetic testing to help researchers gather information about this disease and how and why it affects some patients more than others.
- Trial name
- NCT01194362
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Baylor Research Institute
Tricuspid Regurgitation, Valvular Heart Disease
European Registry of Transcatheter Repair for Tricuspid Regurgitation
To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.
- Conditions
- Tricuspid Regurgitation, Valvular Heart Disease, Heart Failure
- Trial name
- EuroTR (NCT06307262)
- Testing
- T-TEER
- Where
- Germany
- Volunteers
- 3,000 people
- Sponsor
- LMU Klinikum
Tricuspid Regurgitation, Right Heart Failure
The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement
The investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves…
- Trial name
- NCT02644616
- Testing
- tolvaptan+torasemide
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Chest Hospital
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
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR).
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT (NCT02574650)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mitralign, Inc.
Remodeling, Cardiac, Tricuspid Regurgitation
Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation
The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.
- Trial name
- TRAP (NCT03159923)
- Testing
- Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.
- Where
- 17 sites in France
- Volunteers
- 200 people
- Sponsor
- Rennes University Hospital
Tricuspid Valve Disease, Tricuspid Regurgitation
Prehab Prior to Undergoing Tricuspid Intervention
This study will aim to standardize the prehabilitation protocol to optimize patients and document the clinical and echo variables that could improve clinical outcomes of tricuspid valve intervention.
- Trial name
- NCT04665583
- Testing
- Prehabilitation
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Baylor Research Institute