Clinical trials: Mitral Disease
Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
- Trial name
- HeartEpoch (NCT07243184)
- Testing
- mitral valve replacement
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai HeartEpoch Medical Technology Co., Ltd
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, Mitral Valve Disease
The Conveyor Study
To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral…
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03893578
- Testing
- Mitral valve-in-valve
- Volunteers
- 10 people
- Sponsor
- Synecor, LLC
Mitral Regurgitation
MitraClip China PMS
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for…
- Trial name
- NCT04259411
- Testing
- MitraClip procedure
- Where
- 5 sites in China
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
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
Mitral Regurgitation
EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)
The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation.
- Trial name
- EXPLORE-MRace (NCT07517588)
- Testing
- MR-ace Implant and Delivery System
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Polares Medical SA
Mitral Valve Insufficiency
DragonFly EU Pivotal Study
To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk…
- Trial name
- NCT05927441
- Testing
- DragonFly Transcatheter Mitral Valve Repair System
- Where
- Germany
- Volunteers
- 168 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Valve Disease, Mitral Valve Stenosis
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance.
- Conditions
- Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
- Trial name
- FOLDAX (NCT04717570)
- Testing
- Foldax TRIA Mitral Valve
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Foldax, Inc
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Mitral Regurgitation
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve…
- Trial name
- ALERT (NCT06099665)
- Testing
- Automated alert
- Where
- 6 sites in United States
- Volunteers
- 2,118 people
- Sponsor
- Tempus AI
Mitral Valve Insufficiency
CG Future® Annuloplasty Ring/Band Clinical Trial
The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
- Trial name
- NCT01074671
- Testing
- CG Future Annuloplasty Ring/Band
- Where
- 8 sites in Belgium, Germany and 3 more
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Paroxysmal or Persistent, Mitral Valve Disease
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common…
- Trial name
- CoolCryo (NCT06557616)
- Where
- 2 sites in Poland
- Volunteers
- 20 people
- Sponsor
- Medinice S.A.
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or…
- Trial name
- NCT05784337
- Testing
- Mi-thos® Transcatheter Mitral Valve Replacement System
- Where
- 2 sites in China
- Volunteers
- 11 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Mitral Regurgitation
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial…
- Trial name
- NCT05610566
- Testing
- the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - Pilot in Georgia
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-PILOT-GE (NCT05682066)
- Testing
- Innovalve MR system
- Where
- Georgia
- Volunteers
- 11 people
- Sponsor
- Edwards Lifesciences
Mitral Valve (MV) Regurgitation
DragonFly M2 Pivotal Study
To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk…
- Trial name
- NCT07243197
- Testing
- DragonFly M2 Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Cardiac Valve Disease
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and…
- Trial name
- MANTRA (NCT05002543)
- Where
- 52 sites in United States, Austria and 11 more
- Volunteers
- 2,150 people
- Sponsor
- Corcym S.r.l
Mitral Valve Insufficiency
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation…
- Trial name
- NCT04343313
- Testing
- Half Moon TMVr System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Half Moon Medical
Mitral Regurgitation, Mitral Valve Disease
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing…
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis
- Trial name
- NCT06167213
- Testing
- SAPIEN X4 THV
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Valve Disease
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse
- Trial name
- AcChord (NCT04190602)
- Testing
- NeoChord Artificial Chordae Delivery System, Model DS1000
- Where
- 5 sites in Germany, Greece and 1 more
- Volunteers
- 500 people
- Sponsor
- NeoChord