View clinical trials related to Mitral Valve Insufficiency.
Filter by: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.
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
Mitral regurgitation (MR) is a prevalent valvular heart pathology. Indications for surgery include symptoms, impaired left ventricular function or enlarging dimensions, new onset atrial fibrillation, pulmonary hypertension, asymptomatic status with a high likelihood of success. Asymptomatic severe primary MR can be initially monitored without impairing long term survival. However, significant symptoms or impairment of left ventricular function is associated with worse prognosis due to long term heart failure. Some physicians wait for early symptoms before referring for surgery and this is reflected by a great variation in referral patterns, but symptomatic status is subjective and difficult to assess. Nearly all of the surgical indications are based on expert opinion rather than significant evidence base. The primary aim of this project is to improve the current guidelines for surgery for primary MR by finding an objective marker of functional capacity which correlates with surrogates of prognosis and detects early decline, but returns to normal after surgery.
The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.
Since October of 2014, the Policlinico Umberto I Hospital has an "Heart Team", a group of selected specialists with the task of assessing and identifying eligible patients for valvular aortic transcatheter implantation (TAVI) or a placement of a MitraClip . The specialists taking part to Heart Team are: a cardiologist, a heart surgeon, a vascular surgeon, an anesthesiologist and a geriatrician. The Geriatrician is called to make a careful multidimensional assessment of the elderly patients who have been suggested for the interventions mentioned above. His role is to assess the degree of co-morbidity and polypathology, autonomy in the common activities of daily living, nutritional status, cognitive status and quality of life. Following this evaluation, together with the other components of Heart Team, it is expressed a collective judgment on the patient's eligibility to these interventions. So, the aim of the present study is to identify changes in the degree of cognitive decline, of autonomy in carrying out activities of daily living, quality of life, nutritional status, pre- and postoperatively (6 months after the procedure) polypathology degree in elderly patients to be undergone or undergoing TAVI or positioning MitraClip because suffering from aortic valvular stenosis or severe mitral insufficiency. The patients undergo to a battery of tests, to a 5 minutes electrocardiographic record to evaluate the Heart Rate Variability (HRV) and to a complete echocardiographic evaluation.
The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).
Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.
To evaluate the long-term results after transcatheter mitral valve repair
The MitraClip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without clinical manifestations is high. The aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.