Clinical trials: Mitral Valve Regurgitation
Mitral Regurgitation
Cephea Early Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT05061004
- Testing
- Cephea Mitral Valve System
- Where
- 22 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
EFS of the CardioMech MVRS
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
- Trial name
- NCT04820764
- Testing
- CardioMech MVRS
- Where
- 12 sites in United States
- Volunteers
- 35 people
- Sponsor
- CardioMech AS
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Mitral Regurgitation, Mitral Insufficiency
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification
- Trial name
- NCT03539458
- Testing
- Tendyne Mitral Valve System
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Abbott Medical Devices
Functional Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.
- Trial name
- NCT05988450
- Testing
- SQ-Kyrin Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Mitral Insufficiency, Heart Valve Disease
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
- Conditions
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02478008
- Testing
- CardiAQ TMVI System (Transapical DS)
- Where
- 9 sites in Denmark, France and 2 more
- Volunteers
- 2 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Cardiovalve Transfemoral Mitral Valve System
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize mitral regurgitation.
- Trial name
- AHEAD (NCT03813524)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Cardiovalve Ltd.
Heart Failure, Mitral Regurgitation
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
- Trial name
- PTOLEMY (NCT00571610)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Viacor
Gliomas Harboring IDH1 and/or IDH2 Mutations
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1…
- Trial name
- NCT07025018
- Testing
- HMPL-306
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Hutchmed
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
Mitral Regurgitation
Sutra Hemi-valve First-in-Human Study
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for…
- Trial name
- NCT06552689
- Testing
- Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Sutra Medical, Inc.
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Severe Functional Mitral Regurgitation and Heart Failure
Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function
To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.
- Trial name
- LVRECOVER (NCT02153892)
- Testing
- GDS Accucinch System
- Where
- Australia
- Volunteers
- 2 people
- Sponsor
- Ancora Heart, Inc.
Functional Mitral Regurgitation, Atrial Fibrillation
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)
- Conditions
- Functional Mitral Regurgitation, Atrial Fibrillation, Atrial Functional Mitral Regurgitation
- Trial name
- AFIRE (NCT04529928)
- Testing
- Carillon Mitral Contour System
- Where
- 2 sites in Australia, Greece
- Volunteers
- 4 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Mitral Regurgitation
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
- Trial name
- ASCEND (NCT04382612)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 10 sites in Austria, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation Functional
Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically…
- Trial name
- NCT07243158
- Testing
- DragonFly System, Drug
- Where
- China
- Volunteers
- 148 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Leaflet Prolapse
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation.
- Trial name
- NCT01415947
- Testing
- V Chordal
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- Edwards Lifesciences
Functional Mitral Regurgitation
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.
- Trial name
- NCT06583876
- Testing
- Coriofix System
- Where
- 8 sites in Hungary, Israel and 2 more
- Volunteers
- 15 people
- Sponsor
- Bio Refine Ltd.
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.