View clinical trials related to Ischemic Cardiomyopathy.
Filter by:Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV. First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial. For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences. The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.
Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of cardioresynchronization device using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Subsequently, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has showed greater improvement in hemodynamic parameters than with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to biventricular CRT. This method has become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS duration. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP in patients with CRT indications. However, it is not enough data about CRT with LBBP effectiveness in LV remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP compared with conventional biventricular CRT will significantly improve the clinical outcomes and reverse LV remodeling in patients with chronic HF with reduced LV ejection fraction and reduce the number of non-responders to conventional CRT.
Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF). The atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing. In this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy. In our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit. Based on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery. The trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.
Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial
analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty
Context : Ventricular tachycardia (VT) are serious heart rhythm disorders which can lead to sudden death. A curative treatment for these abnormalities in the cardiac electrical conduction system is possible through an interventional electrophysiology procedure. A catheter is inserted, generally via a femoral access, and is introduced in the heart ventricles in order to collect various 3D electro-anatomical maps. The pace-mapping technique developed in Nancy (de Chillou et al, Heart Rhythm 2014) allows the reentrant circuit underlying the VT to be identified, as well as a definition of the target zones to be ablated, using radiofrequency energy with the catheter. The pace-mapping technique consists of stimulating the ventricle from various sites within its internal surface, in order to generate different activation pathways of the myocardium. When an activation pathway is similar to the VT pathway, this means that the stimulation site is located near the pathologic zone to be ablated. The surface electrocardiogram (ECG) is used to compare activation pathways. A 3D correlation ma is then generated: the zones with high correlation (>90%) indicated the exit of the reentrant circuit, while rapid transition zones (several %/mm) indicate the entrance of the VT circuit. The pace-mapping technique has several limitations: (i) it requires an ECG recording of the clinical VT of the patient (spontaneous or induced at the beginning of the procedure), however it is not always possible to induce it; (ii) sometimes several VT circuits may be present, rendering the procedure of identification and ablation non-exhaustive. The aim of this study is to analyze retrospectively electroanatomical data collected during the intervention, in order to develop a new method for identifying target zones to be ablated, and to compare the results with the conventionally used method. Hypothesis : The investigators hypothesize that alternative methods to analyze electroanatomical data (surface ECG and spatial coordinates of the pacing sites) could provide information equivalent to conventional methods (e.g. VT correlation map, VT activation maps etc…) without the need for a reference recording of the clinical VT of the patient.
There is existing data in the literature that suggests an additional predictive value of three dimensional ECG with respect to the presence of electrical abnormalities and for an existing cardiac disease. Especially regarding patients who suffered from a myocardial infarction in the past (post MI patients), evidence has been provided for a potential association of 3D repolarisation abnormalities and incidence of sudden cardiac death (SCD). In addition, there is some vague evidence of so called 3D ECG and prediction of coronary artery disease. This 3D ECG device is using the technology of 3D ECG vector loops and is assessing the variability of these ECG vector loops in the 3-dimensional space. Based on these data, the parameters of 3D ECG are suggested to carry certain value to predict or to identify individuals already suffering from a cardiac disease or being at risk experiencing a cardiac event in the future. In this context we performed a preliminary study with 3D-ECG device in healthy volunteers evaluating the robustness of this method with respect to reproducibility, intra- and intra-observer variability which could be confirmed. We thus postulate that the 3D ECG technology might bear the potential to serve as a sufficient screening method for diagnosing cardiomyopathy in patients with an unknown heart failure etiology.
The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period