Clinical trials: Mitral Valve Repair Surgery
Mitral Valve Insufficiency, Mitral Regurgitation
Acquisition of Objective Data During Transapical Neochordae Implantation
Mitral Valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Implantation of artificial Gore-Tex chordae (or neochordae implantation) is often used for MVr.
- Trial name
- TENSCHORD (NCT04709042)
- Testing
- Chordal tension measurement, Cardiac Magnetic Resonance Imaging (MRI)
- Sponsor
- Hospices Civils de Lyon
Mitral Valve Insufficiency, Coronary Artery Disease
Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation
Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery disease (CAD) may undergo to increase blood flow to the heart.
- Trial name
- NCT00806988
- Testing
- Mitral Valve Repair, CABG
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Coronary Artery Disease, Mitral Valve Insufficiency
Mitral Valve Repair Combined Coronary Artery Bypass Grafting(CABG) Verus CABG Alone on Functional Ischemic Mitral Regurgitation
Coronary artery bypass grafting(CABG) is an effective procedure in treating severe coronary artery disease(CAD). Optimal surgical method for CAD patients with functional ischemic mitral regurgitation(FIMR) is still controversial.
- Trial name
- NCT03525041
- Testing
- CABG, mitral valve annuloplasty
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Beijing Anzhen Hospital
Mitral Regurgitation
MitraClip® After Surgical Mitral Valve Repair
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery.
- Trial name
- MVRepair (NCT02853955)
- Testing
- Percutaneous edge-to-edge repair of the mitral valve
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- LMU Klinikum
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Hypertrophic Obstructive Cardiomyopathy
Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
- Trial name
- PRIZMA-pilot (NCT04470102)
- Testing
- mitral valve repair by edge-to-edge technique, Septal myectomy
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
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 Insufficiency
Multicenter International Trial Ring AnnulopLasty
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included.
- Trial name
- MITRAL (NCT00727012)
- Testing
- mitral valve repair (SJM® Rigid Saddle Ring)
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Surgical Approaches
Transseptal Approach Versus Conventional Left Atrial Approach for Mitral Valve Procedures
Study Objectives/Specific Aims Overall Goal: To compare between transseptal approach and the conventional left atrial approach for mitral valve procedures.
- Trial name
- NCT04078100
- Testing
- Transseptal approach.
- Volunteers
- 100 people
- Sponsor
- Assiut University
Mitral Valve Disease
Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring
Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to complete flexible ring substitutes, the most…
- Trial name
- MEMO 3D (NCT01987635)
- Testing
- MEMO 3D ring, Standard use of rigid ring., 3D Echocardiography
- Where
- Belgium
- Volunteers
- 33 people
- Sponsor
- University Hospital, Ghent
Mitral Valve Repair Surgery
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
This study compares the efficacy and safety of two different antithrombotic drugs, warfarin and aspirin, in early application after mitral valve repair (MVRep).
- Trial name
- NCT06738992
- Testing
- Aspirin, Warfarin
- Where
- China
- Volunteers
- 384 people
- Sponsor
- Guangdong Provincial People's Hospital
Degenerative Mitral Valve Disease, Mitral Regurgitation
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve…
- Trial name
- NCT05836532
- Testing
- Central edge-to-edge
- Where
- Italy
- Volunteers
- 110 people
- Sponsor
- Michele De Bonis
Functional Mitral Regurgitation
Treatment of Moderate FMR During AVR
Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease.
- Trial name
- NCT05566340
- Testing
- mitral valve repair
- Volunteers
- 154 people
- Sponsor
- Fuwai Yunnan Cardiovascular Hospital
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
Degenerative Mitral Valve Disease
Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation
The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to: 1.
- Trial name
- DMR (NCT07605715)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Cedars-Sinai Medical Center
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart…
- Conditions
- Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT02675244
- Testing
- TV Annuloplasty, MVS
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 401 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Valve Disease, Mitral Regurgitation
The Role of Left Atrial Fibrosis in Mitral Valve Repair Surgery (ALIVE Trial)
Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events.
- Conditions
- Mitral Valve Disease, Mitral Regurgitation, Surgery, Cardiac Valve Disease
- Trial name
- ALIVE (NCT05345730)
- Testing
- 3 DImensional Late Enhanced Gadolinium cardiac MRI scan
- Where
- Netherlands
- Volunteers
- 21 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mitral Insufficiency, Pulmonary Arterial Hypertension
Surgical Valvuloplasty for Congenital Mitral Insufficiency
Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly.
- Trial name
- NCT03567668
- Testing
- mitral valvuloplasty
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hong Liu
Mitral Valve Regurgitation
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation
KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques.
- Trial name
- NCT03908983
- Testing
- Kalios Implant
- Where
- 9 sites in Austria, Germany and 2 more
- Volunteers
- 100 people
- Sponsor
- Kephalios