Clinical trials: Mitral Valve Replacement
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 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 Valve Replacement
Replacement of the Native Mitral Valve Using the ReValve System
This study is to collect preliminary chronic information on performance and safety of the ReValve System.
- Trial name
- NCT07601269
- Testing
- ReValve System
- Where
- 2 sites in Brazil
- Volunteers
- 25 people
- Sponsor
- ReValve Solutions Inc.
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
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- Abbott Medical Devices
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
Aortic Valve Disease, Mitral Valve Disease
Artificial Valve Endocarditis Reduction Trial
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Trial name
- AVERT (NCT00590889)
- Testing
- Artificial Mechanical Heart Valve
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 807 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
- Trial name
- PRELUDE (NCT02768402)
- Testing
- Caisson TMVR System
- Where
- 13 sites in United States
- Volunteers
- 20 people
- Sponsor
- Caisson Interventional LLC
Mitral Regurgitation, Valve Heart Disease
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical…
- Conditions
- Mitral Regurgitation, Valve Heart Disease, Heart Valve Diseases, Mitral Valve Disease
- Trial name
- NCT04464876
- Testing
- SATURN TA System
- Where
- 3 sites in Denmark, Hungary and 1 more
- Volunteers
- 20 people
- Sponsor
- InnovHeart
Degenerative Mitral Regurgitation
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative…
- Trial name
- NCT07857343
- Testing
- Microport CardioFlow Mitral Valve Replacement System
- Where
- 3 sites in China
- Volunteers
- 152 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Mitral Regurgitation, Mitral Valve Disease
Munich Transcatheter Mitral Valve Safety and Effectiveness
The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve.
- Trial name
- MUSE (NCT05871983)
- Testing
- MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
- Where
- 10 sites in Argentina, Brazil and 1 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- P+F Products + Features GmbH
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair
The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery.
- Trial name
- MVR + CorCap (NCT00630266)
- Testing
- CorCap CSD
- Where
- 12 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Acorn Cardiovascular, Inc.
Bioprosthesis Failure
Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China)
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China.
- Trial name
- VIV (NCT07174531)
- Testing
- Transcatheter valve in Valve implantation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Beijing Balance Medical Technology Co., Ltd
Mitral Regurgitation, Mitral Valve Disease
Caisson Transcatheter Mitral Valve Replacement (TMVR)
The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Failure, Mitral Disease
- Trial name
- INTERLUDE (NCT03661398)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Caisson Interventional LLC
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT05902897
- Testing
- Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
- Where
- 3 sites in Brazil
- Volunteers
- 913 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Mitral Valve Insufficiency
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
- Trial name
- NCT02322840
- Testing
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Cardiovascular
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
- Trial name
- NCT04195984
- Testing
- Mi-thos® valve and transapical delivery system
- Where
- 3 sites in China
- Volunteers
- 122 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.