Clinical trials: Mitral Regurgitation
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 Valve (MV) Regurgitation
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR).
- Trial name
- ACCESS-EU (NCT01288976)
- Testing
- MitraClip, Medical Management, Mitral Valve Surgery
- Where
- Germany
- Volunteers
- 721 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
The PALMETTO Study
Prospective, single-arm, multicenter, non-randomized early feasibility study
- Trial name
- PALMETTO (NCT07885839)
- Testing
- ReValve System
- Volunteers
- 10 people
- Sponsor
- ReValve Solutions Inc.
Mitral Regurgitation
Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Evaluate the hemodynamic and anatomical effect of the commercially available CMCS system within its current indication on a subset of patients with exercise induced mitral regurgitation.
- Trial name
- EXERCISE FMR (NCT05040451)
- Testing
- Carillon Mitral Contour System
- Sponsor
- Cardiac Dimensions Pty Ltd
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Mitral Valve Insufficiency, Cardiac Valve Annuloplasty
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR).
- Conditions
- Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases
- Trial name
- REPAIR (NCT02703311)
- Testing
- Cardioband
- Where
- 10 sites in France, Germany and 1 more
- Volunteers
- 11 people
- Sponsor
- Edwards Lifesciences
Degenerative Mitral Regurgitation
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation.
- Trial name
- NCT07470788
- Testing
- Transcatheter Mitral Valve Repair
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Vesalius Cardiovascular Inc.
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.
Mitral Regurgitation
Cephea Transseptal Mitral Valve System FIH
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for…
- Trial name
- NCT03988946
- Testing
- Transcatheter Mitral Valve Replacement via Transseptal Access
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Cephea Valve Technologies
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Mitral Regurgitation, Heart Disease
Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)
CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US).
- Trial name
- CASSINI-US (NCT07130994)
- Testing
- Mitral Valve Replacement
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- InnovHeart
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Diseases
A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation
This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation.
- Trial name
- RESHAPE-HF (NCT01772108)
- Testing
- MitraClip
- Where
- 29 sites in Austria, Belgium and 8 more
- Volunteers
- 42 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation, Left Ventricular Dysfunction
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an…
- Conditions
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure
- Trial name
- NCT00120276
- Testing
- Less invasive mitral valve repair
- Where
- 10 sites in United States
- Volunteers
- 250 people
- Sponsor
- Myocor
Mitral Valve Regurgitation
MitraClip REPAIR MR Study
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve…
- Trial name
- NCT04198870
- Testing
- MitraClip™ device implantation, Mitral Valve Repair Surgery
- Where
- 74 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation of Any Grade
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
The study primarily aims to collect standard of care clinical data in a wide spectrum of simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing stand-alone software prototype (QFlow), developed by…
- Trial name
- NCT03286088
- Testing
- TransEsophageal Echocardiography and TransEsophageal Echocardiography, Cardiac Magnetics Resonance, MitraClip
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
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.
Atrophy, Muscular
31P MRS Ischaemic Exercise Optimisation and COPD
An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to obtain a consistent standard of measurement of muscle metabolism while maintaining an acceptable level of subject comfort and use optimised…
- Trial name
- NCT01476072
- Testing
- MRI scan
- Where
- United Kingdom
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline