Clinical trials: Valve Regurgitation, Mitral
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (FR) (NCT07757607)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Mitral Valve Regurgitation
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation
The optimal surgical approach in functional mitral regurgitation (MI) was questioned in favour for prosthetic replacement due to the reduced risk of recurrent MI . However, adjustable mitral rings may provide an alternative .
- Trial name
- NCT03842397
- Testing
- Kephalios Device 1
- Where
- Austria
- Volunteers
- 5 people
- Sponsor
- Kephalios
Mitral Regurgitation, Mitral Stenosis
Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's outcome regarding acute kidney injury.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- Trial name
- NCT02831270
- Testing
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Konkuk University Medical Center
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
Cardiac Surgery, Tricuspid Valve Regurgitation
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs.
- Trial name
- NCT01246947
- Testing
- Tricuspid valve repair, Mitral surgery alone
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- University of Maryland, Baltimore
Mitral Valve Insufficiency
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation
Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation.
- Trial name
- NCT01137734
- Testing
- Adjustable Annuloplasty Ring with option to adjust off pump., Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
- Where
- 2 sites in Belgium, Italy
- Volunteers
- 30 people
- Sponsor
- Edwards Lifesciences
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 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
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
Heart Failure
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter…
- Trial name
- CASSINI-EU (NCT06414265)
- Testing
- Transcatheter mitral valve replacement
- Where
- 8 sites in Georgia, Italy and 3 more
- Volunteers
- 30 people
- Sponsor
- InnovHeart
Mitral Regurgitation, Mitral Stenosis
Cephea South America 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
- NCT07244939
- Testing
- Cephea Mitral Valve System
- Where
- 3 sites in Brazil, Chile
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Disorder of Prosthetic Cardiac Valve
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart…
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- BASS (NCT01334801)
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Mitral Regurgitation
Capstan Medical TMVR Study: FIH
This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral…
- Trial name
- NCT06600191
- Testing
- Capstan System transcatheter mitral valve replacement
- Where
- 4 sites in Australia, Brazil and 2 more
- Volunteers
- 10 people
- Sponsor
- Capstan Medical
Heart Failure, Mitral Regurgitation
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.
- Trial name
- PTOLEMY (NCT00568230)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- Viacor
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Regurgitation, Mitral
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolapse of at least 2 mm beyond the…
- Trial name
- IMPARED (NCT05284058)
- Testing
- Cardiac Magnetic Resonance Imaging (MRI)
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Hospices Civils de Lyon
Mitral Regurgitation
Mitral Splay Sign, Its Mechanism and Association With Severity of Regurgitation
To study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry').
- Trial name
- NCT06152315
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- ITMO University
Severe Mitral Regurgitation, Preserved Ventricular Ejection Fraction
Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery
Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery and it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits.
- Trial name
- DysPO IM (NCT03968601)
- Testing
- Mitral regurgitation surgery such as mitral valve replacement or repair
- Where
- France
- Volunteers
- 79 people
- Sponsor
- University Hospital, Clermont-Ferrand