Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
Heart FailureCardiac Resynchronization TherapyCardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause. The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.
Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With...
Heart FailureArrhythmias1 moreVasco trial is a no profit, multicenter, international, prospective, randomized study designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and left ventricle ejection fraction (LVEF)> 40% .The study will enroll about 331 patients (221 in the ILR group and 110 in the in-hospital follow-up group).
Novel Clinical Utility of Retinal Imaging in Patients With Heart Failure
Heart FailureEndothelial dysfunction and microvascular disease have been shown to play an important role in both the development and progression of heart failure. Retinal imaging provides a unique opportunity to non-invasively assess retinal microcirculation. Leveraging the non-invasiveness and relative ease of use of retinal imaging, we propose to investigate its clinical utility in assessing endothelial/microvascular dysfunction across the spectrum of heart failure. We aim to test the hypothesis that the degree of abnormality in retinal vessels is associated with heart failure disease severity, endothelial/microvascular dysfunction, and, potentially, treatment responses.
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM) in Patients With Idiopathic Peripheral Neuropathy...
Amyloidosis CardiacAmyloid Polyneuropathy5 moreThe goal of the present study is to determine the occurrence of wild-type and hereditary transthyretin amyloidosis cardiomyopathy among patients with the diagnosis of idiopathic peripheral neuropathy in the setting of a state-of-the-art diagnostic work-up; the investigators believe that the identification of patients with ATTR-CM in this setting can contribute to the early diagnosis of a largely underrecognized condition and, therefore, offer conditions to timely initiation of appropriate therapy with impact on prognosis of patients.
Improving CRT Outcome With Non-Invasive Cardiac Mapping
Heart Failure With Reduced Ejection FractionThe ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement. The hypothesis of the investigation is to demonstrate that CRT LV lead implantation guided by a map obtained with the Amycard 01C System and showing LV Latest Electrical Activated Site (LEAS) in combination with a CT cardiac venogram improves CRT outcome. An improved CRT outcome is defined as a ≥30% increase in LVESVi reduction compared to empiric CRT LV lead implantation. The sample size will be 136 in the Control arm and 194 in the Active arm. A total of 330 subjects. The study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. The sponsor may stop enrollment when either one of the following conditions apply: Statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the LVESVi of ≥30% in the Active arm compared to the Control arm There is no trend or reason to believe statistical significance will be reached with a higher sample size. Statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.
Metabolic Inflexibility of the Heart as a Predictor of Occurrence of Heart Failure in Patients With...
Diabetes MellitusType 2In the type 2 diabetic population, some patients are particularly at risk of developing early heart failure. Finding markers to identify these at-risk individuals is therefore an important scientific objective in order to avoid/delay the development of heart failure. The protocol will be proposed to type 2 diabetic patients hospitalized for insulin therapy upon admission to the diabetology department and healthy volunteers.
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
Heart FailureCongestive Heart Failure2 moreThis is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
Heart FailureHeart failure is a common cardiac condition affecting nearly 6 million Americans. Silent blood volume overload is common in patients with heart failure and is associated with increased risk of death. This study is designed to determine if adjustment of therapy based on direct measurement of blood volume will reduce risk of hospitalization and death when compared with therapy based on clinical assessment of blood volume in patients with chronic heart failure.
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Heart FailureCardiac SurgeryHypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit
Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction...
Acute Heart FailureIt is well known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.