View clinical trials related to Mitral Valve Insufficiency.
Filter by:To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
Secondary mitral insufficiency is a common complication of heart failure, aggravating symptoms and prognosis, and may be responsible for worsening dyspnea, pulmonary edema, and excess mortality. It is essentially a ventricular rather than a valvular disease, whose origin may be ischemic or not. It is induced by a geometrical and contractile modification of the left ventricle which causes an imbalance between the tensile and the closing forces of the mitral valve thus causing a defect of coaptation and the increase of the surface between the mitral leaves and the ring in systole (tenting). Dynamic mitral insufficiency is defined by changes in the degree of severity of regurgitation as a function of hemodynamic conditions. During exercise, the course of mitral insufficiency is variable and is not predicted by the degree of regurgitation at rest. The worsening of the leak is also well correlated with the onset of dyspnea on exertion in patients with left Ventricular Ejection Fraction heart failure (LVEF reduced). Nevertheless, there is little data available in the literature on the factors predisposing to the development of stress-related mitral insufficiency, as well as its clinical and echocardiographic impact in the cardiac insufficiency patient, particularly in the case of preserved LVEF (6.7%). The identification of echocardiographic data at rest to predict and anticipate the behavior of mitral insufficiency in the effort (aggravation or stability / disappearance), would allow a simplified evaluation and a better management in this population of patients for which the evaluation in echography of effort can be technically complex and limited (difficulty of quantification of the mitral leak, time of effort sometimes too short ...).
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. The current guidelines recommend surgery in patients with symptomatic severe mitral regurgitation or in asymptomatic patients who develop early signs of left ventricular (LV) dysfunction as a result of the MR. However, it remains difficult to determine optimal timing for surgery with the current guidelines. Early-stage LV dysfunction with normal LVEF predicts post-operative LV decompensation and poor prognosis and longitudinal myocardial function is suitable for detection of minor myocardial damage in patients with MR. Thus, inestigators want to study the value of LV global longitudinal strain (GLS) to predict postoperative LV dysfunction in patients with chronic severe MR and preserved pre-operative LVEF. The principal aim is to prove that the optimal timing for surgery, in asymptomatic chronic severe primary MR with preserved LVEF, is before GLS alteration, and that investigators should not wait for LV dilatation of dysfunction.
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 . In this first-in-man trial, a novel balloon-adjustable mitral-ring was assessed regarding clinical safety and feasibility. 5 patients will be enrolled according to the inclusion/ exclusion criteria and subsequently implanted with the study device. Study visits will be performed preoperatively, perioperatively, at discharge, at 30 days, 3 months and 6 months. Primary outcome parameter will be morbidity and mortality at 30 days following implantation.
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists. Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III). Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist. Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date.
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.
The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to life-saving therapies and reduce the need for costly testing. The FDA-approved Eko Duo device consists of a digital stethoscope and a single-lead electrocardiogram (ECG), which wirelessly pairs with the Eko Mobile application to allow for simultaneous recording and visualization of phono- and electrocardiograms. These features uniquely situate this device to accumulate large sets of auscultatory data on patients both with and without VHD. In this study, the investigators seek to develop an automated system to identify VHD by phono- and electrocardiogram. Specifically, the investigators will attempt to develop machine learning algorithms to learn the phonocardiograms of patients with clinically important aortic stenosis (AS) or mitral regurgitation (MR), and then task the algorithms to identify subjects with clinically important VHD, as identified by a gold standard, from naïve phonocardiograms. The investigators anticipate that the study has the potential to revolutionize the diagnosis of VHD by providing a more accurate substitute to traditional auscultation.