Clinical trials: Mitral Valve Disease
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
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 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.
Mitral Valve Regurgitation
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Trial name
- MAVERIC (NCT02302872)
- Testing
- ARTO System
- Where
- 9 sites in Australia, France and 3 more
- Volunteers
- 51 people
- Sponsor
- Mvrx, Inc.
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 Valve Insufficiency, Mitral Valve Prolapse
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative, Mitral Regurgitation
- Trial name
- NCT05425628
- Testing
- NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
- Volunteers
- 30 people
- Sponsor
- NeoChord
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective 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…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Functional Mitral Regurgitation
Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
- Trial name
- LVRESTORESA (NCT01899573)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- Colombia
- Volunteers
- 8 people
- Sponsor
- Ancora Heart, Inc.