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The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.
Mardil Medical is developing an investigational device for functional mitral regurgitation intended to provide ventricular support with adjustable inflatable chambers to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation. In doing so, Mardil Medical is interested in exploring the anatomical and geometric annular and ventricular changes that occur when strategically positioned external inflatable chambers are applied to the outside of the heart. Favorable benefits of circumferential reduction in ventricular wall stress favoring left ventricular (LV) remodeling and acute reshaping of LV segments subtending the deformed mitral valve apparatus needs to be better understood. Mardil Medical is pursuing this study as an initial phase in the Acute Evaluation of Anatomical and Geometric Changes using the Bladder on a Stick System (BOSS).
Functional Mitral Regurgitation
Henry Ford Health System
Not yet recruiting
Published on BioPortfolio: 2017-07-25T12:38:21-0400
This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgit...
At present, the optimal treatment strategy for heart failure patients and moderate-to-severe (3+) or severe (4+) mitral regurgitation with a class IIa recommendation for CRT is uncertain.W...
To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
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To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
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Mitral regurgitation is the most common valve disease in the United States. This article focuses on a new percutaneous mitral valve treatment for chronic degenerative mitral regurgitation.
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Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated S...
To determine the prevalence of mitral regurgitation (MR) in a large cohort of consecutive patients undergoing clinically indicated echocardiography and to examine the distribution of primary and secon...
Backflow of blood from the LEFT VENTRICLE into the LEFT ATRIUM due to imperfect closure of the MITRAL VALVE. This can lead to mitral valve regurgitation.
Abnormal protrusion or billowing of one or both of the leaflets of MITRAL VALVE into the LEFT ATRIUM during SYSTOLE. This allows the backflow of blood into left atrium leading to MITRAL VALVE INSUFFICIENCY; SYSTOLIC MURMURS; or CARDIAC ARRHYTHMIA.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Narrowing of the passage through the MITRAL VALVE due to FIBROSIS, and CALCINOSIS in the leaflets and chordal areas. This elevates the left atrial pressure which, in turn, raises pulmonary venous and capillary pressure leading to bouts of DYSPNEA and TACHYCARDIA during physical exertion. RHEUMATIC FEVER is its primary cause.
A type of heart valve surgery that involves the repair, replacement, or reconstruction of the annulus of the MITRAL VALVE. It includes shortening the circumference of the annulus to improve valve closing capacity and reinforcing the annulus as a step in more complex valve repairs.
Cardiovascular disease (CVD)
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