View clinical trials related to Mitral Valve Insufficiency.
Filter by:The timing of surgical intervention in asymptomatic patients with severe degenerative mitral regurgitation (MR) remains controversial. The benefit of early surgery has been suggested in prospective, observational studies, whereas a watchful waiting strategy seemed to be safe and effective in the other prospective study. The consensus guidelines for the performance of early surgery in asymptomatic patients with severe MR are different, reflecting controversy. Clinical outcome in asymptomatic patients with MR is poorly defined and it is important to identify high-risk patients in whom early surgery may be warranted. Thus, the investigators try to compare long-term outcomes of early surgery with those of a conventional-treatment strategy in a large prospective cohort of asymptomatic patients with severe degenerative MR using a propensity analysis, and to identify high-risk subgroups to whom early surgery is more beneficial.
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.
The purpose of this study is to evaluate the immediately clinic and ultramicroscopic myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested heart versus on-pump empty beating heart surgical techniques.
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation. Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017. As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints) As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated Study Completion Date is July 2024. COAPT CAS completed recruiting subjects in March 2019.
Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary arterial pressure due to severe mitral valve regurgitation without compromising systemic hemodynamics. Therefore, the effects of a brief inhaled milrinone (IH) on pulmonary artery pressure are determined and compared to those of intravenous milrinone (IV) in severe mitral regurgitation patients undergoing mitral valve surgery.
This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.
Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. The aim of this study is to evaluate the performance and safety of the Cardioband for repair of mitral regurgitation.
The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation. A single center, prospective cohort study
The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic resonance imaging (CMR) as the non-invasive "gold standard" compared to transthoracic echocardiography (TTE) to evaluate measurements of the width of the regurgitation jet (vena contracta (VC)) to demonstrate the utility of the VC as a means to objectively evaluate atrioventricular valve regurgitation. In addition, feasibility and other quantitative and qualitative measures of regurgitation will be compared between CMR and TTE. - Hypothesis 1: The ability to objectively evaluate atrioventricular valve regurgitation and VC width with TTE and CMR has a high feasibility rate with acceptable intra and inter-observer variability by two independent readers. - Hypothesis 2: There will be positive correlation between the TTE measurement of the VC width and quantitative assessment of atrioventricular valve regurgitation by TTE and CMR. - Hypothesis 3: There will be a positive correlation between the quantitative measurements of atrioventricular valve regurgitation by phase contrast velocity encoded CMR with quantitative values as measured by TTE. - Hypothesis 4: There will be a positive correlation between qualitative assessment of atrioventricular valve regurgitation by CMR compared to TTE.
The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.