Clinical trials: Valve Regurgitation, Tricuspid
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
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 Regurgitation Functional
Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who…
- Trial name
- Pivot TR (NCT07385625)
- Testing
- Pivot Bridge
- Where
- 4 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Tricuspid Regurgitation
Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation
The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.
- Trial name
- NCT04921605
- Testing
- DragonFly transcatheter mitral valve clamping system
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
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 Valve Regurgitation
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
- Trial name
- bRIGHT (NCT04483089)
- Testing
- Transcatheter heart valve procedure
- Where
- 25 sites in Austria, Denmark and 6 more
- Volunteers
- 511 people
- Sponsor
- Abbott Medical Devices
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
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
Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System
The present clinical trial is performed to evaluate the effectiveness and safety of transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Healthcare technology Co.,Ltd.
- Trial name
- TriStar (NCT05173233)
- Testing
- Transcatheter Annuloplasty
- Volunteers
- 67 people
- Sponsor
- Shanghai Huihe Medical Technology Co., Ltd
Tricuspid Regurgitation
Trisol System EFS Study
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
- Trial name
- NCT04905017
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Trisol Medical
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 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 Regurgitation (TR)
The TRICURE US IDE Pivotal Study
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
- Trial name
- TRICURE US IDE (NCT07528326)
- Testing
- TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System
- Where
- United States
- Volunteers
- 831 people
- Sponsor
- TRiCares
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
Murmur, Heart, Aortic Valve Stenosis
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML…
- Conditions
- Murmur, Heart, Aortic Valve Stenosis, Tricuspid Regurgitation, Mitral Regurgitation
- Trial name
- NCT04400513
- Testing
- Use of Eko CORE and Eko DUO electronic stethoscopes
- Where
- United States
- Volunteers
- 1,145 people
- Sponsor
- Eko Devices, Inc.
Tricuspid Regurgitation
The TRICURE First in Human Trial
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver…
- Trial name
- TRICURE (NCT05126030)
- Testing
- Topaz TTVR System
- Where
- 11 sites in Belgium, France
- Volunteers
- 20 people
- Sponsor
- TRiCares
Tricuspid Regurgitation
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled.
- Trial name
- NCT04289870
- Testing
- Trillium™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Innoventric LTD
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 Regurgitation
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate…
- Trial name
- NCT05556460
- Testing
- DragonFly-T Transcatheter Tricuspid Valve Repair System, Medical therapy
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
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