View clinical trials related to Bundle-Branch Block.
Filter by:The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy. This clinical investigation is a prospective, two-arm, randomized 1:1, multicenter feasibility study designed to evaluate the effectiveness of LV only with multipoint pacing (MPP) and SyncAV compared to bi-ventricular pacing with MPP and SyncAV. The clinical investigation will be conducted at approximately 7 centers in Europe and Canada. Approximately 120 subjects will be enrolled in the study. No site may enroll more than 33% of the total subjects. Data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant. Enrollment data collection will include demographics, cardiovascular history, medication, echocardiography measurements and quality of life questionnaire. CRT implant procedure data collection will include implanted system information and lead location. The electrical conduction recording procedure will include surface ECG and device IEGM recordings during various pacing configurations at implant or up to 45 days post implant. In patients who consent to invasive measurements (expected target of at least 80 patients), a hemodynamic recording procedure will include invasive hemodynamic measurements during various pacing configurations which may take place during device implant or up to 45 days post implant. Hospital pre-discharge data collection will take place within 3 days after the CRT implant, electrical conduction recordings visit or hemodynamic recordings visit and will include system information, surface ECG, and device IEGMs. In a subset of patients from selected centers that have access to this technology (expected 20 patients), non-invasive electrical activation data will be collected with body surface mapping within 45 days of the implant procedure. Patients will be randomized 1:1 to receive either biventricular pacing with multipoint pacing (MPP) or LV-only pacing with MPP at the one-month (± 15 days) visit. The 6-month (± 15 days) post randomization follow up visit will include surface ECG, IEGMs, echocardiographic parameters and quality of life questionnaire. Subjects participating in this clinical investigation will follow the hospital center standard of care from implant to 6 month follow up. The expected duration of enrollment is 1.5 year. The total duration of the clinical investigation is expected to be 2 years.
RATIONALE: Cardiac resynchronization therapy (CRT) is known to improve cardiac performance and to reduce morbidity and mortality in reduced-ejection fraction heart failure (HFrEF) despite optimal medical therapy (OMT). Several studies have shown that patients with with left bundle branch block (LBBB) respond favourably to CRT, whereas there is less certainty about non-LBBB morphology. Specifically, whether patients with right bundle branch block (RBBB) and HFrEF benefit from CRT is unclear. Some studies suggest lack of favourable outcomes. It follows from this that VVI implantable defibrillator are implanted in most RBBB patients.On the other hand right ventricular bifocal stimulation could be useful as an alternative approach in patient with RBBB. It consists of two endocardial leads implanted in right ventricle. The first lead is implanted in His bundle area, and the second lead is in the right ventricle apex. In this way bifocal pacing could decrease the inter- and intraventricular delays, thus improving left ventricular hemodynamics. However no specifically randomized studies are designed to date. PURPOSE: To demonstrate the superiority of right ventricular bifocal stimulation over placebo (VVI implantable defibrillator) in RBBB and HFrEF despite OMT. DESIGN Multicenter prospective randomized, double blind cross-over study. MASKING Investigator responsible for device programming is masked from having knowledge about clinical, functional, and echocardiographic data. On the other hand echocardiographist is masked from having knowledge about stimulation mode. Patients are masked from having knowledge about their clinical, functional, and device data. POPULATION At least fifty patients would be enrolled. The enrollment period should be one year. Study overall duration should be two years. ELIGIBILITY CRITERIA RBBB and HFrEF (left ventricular ejection fraction ≤35%) in sinus rhythm, in NYHA class II-III or ambulatory IV despite OMT. EXCLUSION CRITERIA -Refusal or withdrawal of informed consent.Renal failure (glomerular filtration rate ≤ 60 ml/min).Life expectancy < 12 months.Active neoplasm.Permanent atrial fibrillation.40 days following acute coronary syndrome.Atrio-ventricular block (from second degree AV block).Valvular heart disease with surgery indications. PROTOCOL Each patient undergoes baseline assessment. Pharmacological therapy, hospitalization,NYHA functional class, QRS complex informations, type of heart disease and comorbidities are collected. Quality of life (QOL) is defined by Minnesota Living with Heart Failure questionnaire. Functional capacity is assessed by 6MWT (optionally by cardiopulmonary exercise test). Trans-thoracic echocardiogram is performed, analyzing: left-ventricle diameters and volumes, left-ventricle ejection fraction (LVEF), left atrial diameter and area, TAPSE,valvulopathy,systolic pulmonary artery pressure. All patients undergo bifocal right ventricular resynchronization therapy: right atrial lead is implanted, whereas the first ventricular lead is placed in His bundle area, and the second ventricular lead in the right ventricle apex. Then the leads are connected to the respective channels of a CRT-D generator.After the implant, all devices are programmed in VVI mode. After the first 40±10 days (first f-up) patients are 1:1 randomized to VVI mode 40 beats/minute (placebo arm) or bifocal DDD-mode 60 beats/minute (with VV delay 0 msec and optimal AV delay). After six months (second f-up) a clinical and instrumental assessment equal to baseline is performed, as well as devices electrical parameters control. Then arms cross-over is performed (from VVI-mode to bifocal DDD-mode and vice versa). At 12 months (end of follow-up) an evaluation equal to that performed at 6 months is assessed. Echocardiographic data are unravelled to the investigator responsible for device programming. In this way the stimulation mode able to determine the best clinical improved (VVI or bifocal DDD mode) is programmed and the study closes. PRIMARY ENDPOINT The main assumption is that bifocal stimulation can increase of at least 20% the distance walked during 6MWT in respect of baseline and VVI-mode.The primary endpoint is the distance walked (expressed by meters) during 6MWT, as assessed at baseline, 6-months follow-up and 12 months follow up. Specifically changes in 6MWT observed during bifocal DDD-mode compared to baseline and to VVI mode would be significative if there is an increase of at least 20%. SECONDARY ENDPOINT Secondary endpoint is bifocal stimulation therapy response, defined by at least one of the following criteria, evaluated at baseline, 6-months follow-up and 12 months-follow-up in comparison to baseline and VVI mode: NYHA functional class improvement; changes in 6MWT, defined by an increase in distance walked major or equal to 30%; LVEF improvement major or equal to 25%;Left ventricular telesystolic volume reduction major or equal to 15%
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets. Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden). Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.
CRT is delivered from two electrodes on opposite sides of the heart [right (RV) and left ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility in the sequence and temporal staggering of the stimulation from these two electrodes with a different optimum for different patients. However, standard techniques to figure out the optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250 electrode surface recording combined with CT scan to reconstruct high resolution 4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for optimal programming of CRT.
In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) postero-lateral wall. A significant proportion of apparently suitable patients fail to benefit from CRT. One of the problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary vein. LV septal pacing may be a good alternative for BiV pacing in patients with an indication for CRT.
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.
Heart failure is a leading cause of morbidity and mortality. Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with symptomatic heart failure in spite of optimised medical treatment (OMT), reduced left ventricular pump function with left ventricular ejection fraction (LVEF) ≤ 35% and prolonged activation of the ventricles (bundle branch block: BBB). CRT is established by implanting an advanced pacemaker system with three leads in the right atrium, right ventricle, and in the coronary sinus (CS) for pacing the left ventricle (LV), and often is combined with an implantable defibrillator (ICD) function. On average, CRT treatment improves longevity, quality of life and functional class, and reduces heart failure symptoms. Thus, at present, CRT is indicated for heart failure patients on OMT with BBB or chronic right ventricular (RV) pacing. It is, however, a significant problem that 30-40% of CRT patients do not benefit measurably - showing symptomatic improvement or improved cardiac pump function - from this therapy (socalled non-responders). LV lead placement is one of the major determinants of beneficial effect from CRT. Observational studies and three randomised trials with small sample sizes indicate that targeted placement of the LV lead towards a late activated segment of the LV may be associated with improved outcome. Based on this literature, some physicians already search for late activation when positioning the LV lead. However, such a strategy was never tested in a controlled trial with a sample size sufficient to investigate important clinical outcomes. Detailed mapping for a late activation may increase operating times and infection risk, result in use of more electrodes and wires, thereby increasing costs, and increase radiation exposure for patient and staff. Placement of the LV lead in late activated areas close to myocardial scar may even result in higher risk of arrhythmia and death. At present, it is completely unsettled whether targeted positioning of the LV lead to the latest electrically activated area of LV is superior to contemporary standard CRT with regard to improving prognosis for patients with heart failure and BBB. The present study aims to test whether targeting the placement of the LV lead towards the latest electrically activated segment in the coronary sinus branches improves outcome as compared with standard LV lead implant in a patient population with heart failure and CRT indication.
The investigators sought to evaluate the morphological and functional changes, risk stratification and prognosis of patients of participants with compete left bundle branch block (CLBBB). The conduction of this study was largely due to the increased clinical requirement, which reflected the increased awareness among physicians of heart failure due to asynchronous cardiac function caused by CLBBB. The investigators also aim to figure out the time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.
Background: Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness of breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may be lifesaving. AV-block in younger can be seen along with structural or ischemic heart disease, congenital heart disease (incl. congenital AV-block) storage disorders, specific muscle diseases, sarcoidosis, Borrelia infection or drug intoxication. AV-block in younger can also be seen in conditions, primarily localized to the AV-node without other cardiac disease at diagnosis. This form of AV-block is often hereditary and can be seen in families where relatives have another types of heart disease in form of fore example, cardiomyopathy, ion channel disease or sudden death. The different forms of presentation are due to the same gene mutation being expressed differently within the same family. Thus, early onset of AV-block (<50 years) may indicate hereditary AV-conduction disorder but it can also be the first manifestation of severe ion channel disease or cardiomyopathy. Denmark has annually over 50 individuals <50 years treated with pacemaker due to advanced AV-block. There have been no overall figures regarding the causes of advanced AV-block, and therefore no systematic approach to diagnosing this group of patients. Furthermore, the prevalence of individuals with a genetic cause of AV-block is unknown and presumably an often overlooked diagnosis among younger patients with advanced AV-blok. There are no data on disease progression after diagnosis, and therefore there is no evidence-based knowledge about how these patients should be followed after diagnosis. With modern gene technology, a range of new, yet unknown genes with potentially pathogenic mutations is likely to be identified. Identification of such genes, and the development of a strategy for systematic approach to diagnose younger patients with AV-block, will enable presymptomatic genetic screening of relatives and implementation of evidence-based, preventive treatment with pacemaker and/or medical treatment for heart failure based on a specific genetic predisposition for development of AV-block with or without heart failure. Hypotheses: In a significant proportion of younger patients with advanced AV-block the underlying cause is unknown. Objective: To investigate the prevalence and causes of advanced AV-block in younger patients in Denmark and describe the current diagnostics. Method: The study is a cross sectional study. The patients for this study are identified from Danish Pacemaker and ICD Register. The investigators will review medical records and obtain clinical information and test results (see detailed description). Perspectives: This study is the first part of a large study of AV-block in younger patients in Denmark. The overall goal, is to increase knowledge about the causes of and disease progression after the diagnosis of advanced AV-block in young patients which could lead to a significant improvement in the treatment of this patient group and may lead to a customized choice of pacemaker type in the future and perhaps additional medical treatment in this patient group. This could potentially lead to a reduction in both their morbidity mortality.