Clinical trials: Tricuspid Insufficiency
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
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
Tricuspid Valve Insufficiency
Transcatheter Interventions for Tricuspid Insufficiency in Italy
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment.
- Trial name
- TRIC-IT (NCT04735003)
- Testing
- Transcatheter tricuspid valve interventions
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Marianna Adamo
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR), Tricuspid Regurgitation
- Trial name
- NCT07140562
- Testing
- Tricuspid Annular Therapy System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- Tangent Cardiovascular Inc.
Tricuspid Valve Regurgitation, Heart Valve Diseases
TRISCEND JAPAN Study
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe…
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRISCEND JAPAN (NCT05760989)
- Testing
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Where
- 8 sites in Japan
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation
This study is a prospective design. Patients are severe tricuspid regurgitation (TR) (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment.
- Trial name
- NCT05671640
- Testing
- DragonFly-T Transcatheter Tricuspid Valve Repair System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
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
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.
Tricuspid Regurgitation, Pulmonary Regurgitation
Berlin Registry of Right Heart Interventions
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo.
- Trial name
- NCT04570163
- Testing
- Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Tricuspid Regurgitation
MitraClip for Severe TR
The aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in selected, highly symptomatic patients with severe…
- Trial name
- TVrepair (NCT02863549)
- Testing
- MitraClip in tricuspid valve
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- LMU Klinikum
Severe Tricuspid Regurgitation
International Multisite Transcatheter Tricuspid Valve Therapies Registry
For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with…
- Trial name
- TriValve (NCT03416166)
- Testing
- Transcatheter Tricuspid Intervention
- Where
- Switzerland
- Volunteers
- 269 people
- Sponsor
- University of Zurich
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
Tricuspid Valve Insufficiency
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened.
- Trial name
- RIGHT (NCT03278418)
- Testing
- Tricuspid Valve Repair, Left-sided valve surgery
- Where
- 4 sites in Italy
- Volunteers
- 280 people
- Sponsor
- Ettore Sansavini Health Science Foundation
Tricuspid Regurgitation, Heart Failure
Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to…
- Trial name
- NCT04570098
- Where
- Germany
- Volunteers
- 1,016 people
- Sponsor
- Charite University, Berlin, Germany
Tricuspid Regurgitation
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.
- Trial name
- BvsRR (NCT03144024)
- Testing
- band implantation, rigid ring implantation
- Where
- Russia
- Volunteers
- 308 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Tricuspid Regurgitation
Tricuspid RegUrgitaTion Hamburg Cohort
Tricuspid regurgitation (TR) is frequent and has been directly related to high mortality rates. The pathophysiology of TR is mainly functional as it occurs predominantly in the context of left-sided heart disease, pulmonary…
- Trial name
- TRUTH (NCT04755842)
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Right Heart Failure
Accelerated LBBP for Patients With RHF and Severe TR
This study is a prospective, single-arm, target value clinical trial. We plan to prospectively enroll and follow 24 patients across three centers nationwide who have a low baseline heart rate (HR ≤ 60 bpm), meet the indication…
- Trial name
- ARCP (NCT07470047)
- Testing
- permanent pacemaker implantation
- Where
- 3 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai Zhongshan Hospital
Tricuspid Regurgitation
TriClip Japan Post-Approval Study
The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following…
- Trial name
- TriClip JP PAS (NCT07509658)
- Testing
- The TriClip System
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices
Functional Tricuspid Regurgitation
Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.
Interest in tricuspid valve disease has grown exponentially over the past few years, in response to increased interest in the poor prognosis of patients with functional tricuspid regurgitation (TR).
- Trial name
- NCT05836415
- Testing
- Tricuspid valve annuloplasty with 3D ring
- Where
- Italy
- Volunteers
- 168 people
- Sponsor
- Michele De Bonis
Severe Tricuspid Regurgitation
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
- Trial name
- PATHFINDER (NCT07321899)
- Testing
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Where
- 13 sites in United States
- Volunteers
- 1,186 people
- Sponsor
- Medtronic Cardiovascular