Clinical trials: Tricuspid Valve Insufficiency
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
Tricuspid Regurgitation
Clinical Study of Edwards Cardioband FIT Valve Repair System
Clinical Study of the Edwards Cardioband FIT Repair System
- Trial name
- NCT03382457
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
EFS of the DUO System for Tricuspid Regurgitation
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- TANDEM II (NCT05913908)
- Testing
- DUO Transcatheter Tricuspid Coaptation Valve System
- Where
- 18 sites in United States, Poland
- Volunteers
- 15 people
- Sponsor
- CroiValve Limited
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
TRISCEND II Pivotal Trial
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- NCT04482062
- Testing
- Edwards EVOQUE System, Optimal Medical Therapy
- Where
- 62 sites in United States, Germany
- Volunteers
- 864 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery.
- Trial name
- NCT05436028
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- France
- Volunteers
- 161 people
- Sponsor
- Jenscare Scientific
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 Valve Regurgitation, Tricuspid Valve Disease
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases
- Trial name
- TRIVITA (NCT07516444)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
- Where
- United States
- Volunteers
- 730 people
- Sponsor
- VDyne, Inc.
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 Regurgitation
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients…
- Trial name
- SPACER (NCT07172477)
- Testing
- Pivot Extend
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Tau Medical Australia Pty Ltd
Mitral Regurgitation, Tricuspid Regurgitation
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation.
- Conditions
- Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
- Trial name
- ARB-PMCF (NCT04761120)
- Testing
- Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring, Abbott SJM Tailor Ring
- Where
- 17 sites in United States, Estonia and 5 more
- Volunteers
- 550 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation
TTVR Early Feasibility Study
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a…
- Trial name
- NCT04433065
- Testing
- Intrepid™ TTVR System
- Where
- 20 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Regurgitation, Heart Valve Diseases
The CLASP III TR CED Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the…
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT07859709
- Testing
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- Edwards Lifesciences
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
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
- Trial name
- NCT06212193
- Testing
- Trillium™
- Where
- 12 sites in United States, Germany
- Volunteers
- 15 people
- Sponsor
- Innoventric LTD
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
Functional Tricuspid Regurgitation
Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR
Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
- Trial name
- NCT05648838
- Testing
- Pivot Balloon Catheter
- Where
- 10 sites in South Korea
- Volunteers
- 7 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
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.
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid…
- Conditions
- Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD)
- Trial name
- TRIUMPH (NCT07687485)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
- Volunteers
- 700 people
- Sponsor
- Laplace Interventional, Inc
Symptomatic Severe Tricuspid Regurgitation
Transcatheter Treatment of Tricuspid Valve Regurgitation
Tricuspid Regurgitation induces an asymmetric enlargement of the tricuspid valve (TV) annulus causing a reduction of leaflets coaptation. Annular dilation continues even after surgical treatment.
- Trial name
- NCT06093828
- Testing
- TriFlo Tricuspid Flow Optimizer
- Where
- 4 sites in Italy
- Volunteers
- 40 people
- Sponsor
- TriFlo Cardiovascular, Inc.
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