Clinical trials: Mitral Valve Replacement, active
Mitral Annular Calcification, Mitral Stenosis
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥…
- Conditions
- Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
- Trial name
- MITRAL-II (NCT04408430)
- Testing
- Transseptal ViMAC
- Where
- 17 sites in United States, Mexico
- Volunteers
- 210 people
- Sponsor
- Mayra Guerrero
Mitral Valve Insufficiency, Coronary Artery Disease
Long Term Follow Up for CTSN Mitral Valve Repair Studies
This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about…
- Trial name
- NCT03066050
- Testing
- MV Repair, MV Replacement, CABG
- Where
- 24 sites in United States, Canada
- Volunteers
- 368 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Regurgitation
Tendyne European Experience Registry
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.
- Trial name
- TENDER (NCT04898335)
- Testing
- Tendyne Mitral Valve System
- Where
- 30 sites in Austria, Belgium and 8 more
- Volunteers
- 400 people
- Sponsor
- LMU Klinikum
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.
Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
- Trial name
- TIAMAR (NCT05310461)
- Testing
- Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement, Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
- Where
- 3 sites in Switzerland
- Volunteers
- 80 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Mitral Stenosis, Mitral Valve Insufficiency
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant…
- Trial name
- MOMENTIS (NCT05526560)
- Testing
- MITRIS RESILIA Mitral Valve, Model 11400M
- Where
- 34 sites in United States, Canada and 2 more
- Volunteers
- 504 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- The REsOLVE Tr (NCT07450911)
- Testing
- ReValve System
- Where
- 3 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- ReValve Solutions Inc.
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
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.
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
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
Degenerative Mitral Valve Disease
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve…
- Trial name
- NCT03674593
- Testing
- Mitral valve chordae prosthesis, Mitral valve chordae translocation
- Where
- Russia
- Volunteers
- 64 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Aortic Stenosis With Bicuspid Valve
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs)…
- Trial name
- TAILOR-TAVR (NCT05511792)
- Testing
- TAVR for BAV Using Down Sizing with the Evolut Pro platform, TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform
- Where
- 15 sites in China
- Volunteers
- 206 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Mitral Regurgitation
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in…
- Trial name
- APOLLO-EU (NCT05496998)
- Testing
- Medtronic Intrepid™ TMVR TF System
- Where
- 38 sites in Denmark, France and 6 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiovascular
Mitral Valve Regurgitation (Degenerative or Functional)
Edwards EVOQUE Eos MISCEND Study
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Trial name
- NCT02718001
- Testing
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Where
- 19 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
- Trial name
- NCT04775108
- Testing
- Epygon™ Transcatheter Mitral Valve System
- Where
- 10 sites in Austria, Italy and 2 more
- Volunteers
- 40 people
- Sponsor
- Epygon
Mitral Regurgitation, Mitral Valve Insufficiency
The ENCIRCLE Trial
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are…
- Trial name
- ENCIRCLE (NCT04153292)
- Testing
- SAPIEN M3 valve and dock
- Where
- 54 sites in United States, Australia and 4 more
- Volunteers
- 786 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
This is an early study of a catheter-based minimally invasive procedure called SESAME to slice thick heart muscle as described below.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction, Systolic Anterior Motion
- Trial name
- NCT07806149
- Testing
- SESAME Procedure
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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 Valve Disease
Hamburg TranscathEteR Mitral Valve REplacement RegiStry
The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that…
- Trial name
- HERMES (NCT04914468)
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf