View clinical trials related to Arrhythmia.
Filter by:The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".
The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).
The electrocardiogram (ECG) is an important diagnostic procedure in medicine mainly to detect circulation disorders and problems of the spread of the electrical heart impulse. It is frequently the first measure in clinical practice when angina pectoris, acute myocardial infarction or an arrhythmia are suspected. The ECG is easy to perform, safe and cheap. Posture changes are known to cause alterations of the ECG [1]. Deviation of the electrical heart axis (EHA) [2], temporary changes of the QRS morphology and ST-segment alterations are of particular importance in view of diagnostic accuracy [3], [4]. In ambulatory ECG recordings ST-segment alterations for instance might mistakenly be interpreted as cardiac ischemia [5]. Artifacts could be minimized by the concurrent determination of the deviation of the electrical heart axis [6] [7]or by using posture detectors [8] helping to correlate ECG changes to posture changes. Due to the emergence of new computer based opportunities ambulatory ECG in the sense of home monitoring is an emerging market. Together with the superiority compared to the scalar ECG in detecting certain pathologies, like myocardial infarction and right ventricular hypertrophy, the VCG gained new interest in recent years [9]. Four ECG leads are sufficient to synthesize a standard 12-lead ECG from a VCG and vice versa with a transformation matrix [10] [11].The redirection of the spatial VCG after posture changes has been determined for the QRS loop with the Frank leads, which is the reference method for constructing the VCG [12][13]. 4 leads of an ambulatory ECG are sufficient to construct the VCG if arranged approximately in the position of three rectangular axes. Doctors are best trained to interpret standard 12 lead ECGs. With optimization of the leads of ambulatory (Holter) ECG towards the three rectangular axes, this might allow mathematical transformation into the standard 12 lead ECG. A precondition would be that the transformation matrix is independent of posture. To date, transformation matrix between Frank VCG and standard 12 lead ECG has only been calculated in resting ECGs [5]. This is the first study which investigates the transformation matrix in different postures. Additionally, the investigators will investigate for the first time prospectively for known artefacts of stress testing and ambulatory ECGs. Aim: Simultaneous prospective recording of the standard 12 lead ECG and the Frank-lead VCG in different postures is expected to add information on potential causes of artifacts of the ECG caused by posture changes. During continuous recording, the investigators will investigate the accuracy of the linear affine transformation with posture, the occurrence (dimension and duration) of ECG/ VCG morphology changes and ST-segment alterations, and VCG angle changes in dependence of posture changes in healthy young men. Hypothesis The investigators hypothesis is that the transformation matrix between Frank-Lead VCG and standard 12-lead ECG is posture dependent. Artefacts of the ECG due to posture changes are systematic. The knowledge of the systematics improves the diagnostic accuracy of ambulatory ECG and stress testing.
Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. These catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. In the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized. When sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (EGM). To produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the EGM. The distance between the two electrodes varies from device to device. The greater the distance between them, the less accurate the measurement of local electrical activity becomes. This may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (<1 mm apart) with the hope of improving the sensing capability of the device. This study will analyze the signals obtained from this FDA-approved catheter in people undergoing a catheter ablation procedure. The study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. The goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.
The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG. The electrodes are dry, textile ECG electrodes. The garment is designed to position the electrodes in the appropriate anatomical locations, without any special guidance. The dry electrodes are made from unique yarns with silver embedded into the garment using a proprietary technique developed by HealthWatch (HW)that obviates the need for skin preparation or the application of fluids. The garment can be connected to any standard ECG device available in the hospitals. The purpose of this study is to evaluate the safety and effectiveness of the Master Caution Garment for continuous monitoring of ECG signal compared to standard gel electrodes. The following endpoints will be evaluated in subjects participating in the study: Primary: Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes using standard ECG devices. Secondary: Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes when event is detected by the ECG devices.
Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long term despite the use of many effective drug treatment in reducing morbidity and mortality. In this context, cardiac resynchronization (CR), either alone or combined with a defibrillator function, has improved by about 30 to 40% of morbidity and mortality in this population of patients with heart failure. The information on the CR are now well established for patients with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%), presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal. As a result, the number of implanted devices continue to grow even if the implant procedures of cardiac resynchronization devices (CRD) are long, difficult and associated with significant complications with a risk of reoperation estimated between 10 and 15% . One of the most feared during implantation devices stimulation or defibrillation risk is represented by the risk of infection that will lead inevitably to explantation of the device. Despite the use of several preventive measures, including the use of an antiseptic shower, a local preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic prophylaxis clinical studies the most recent have clearly demonstrated that the risk of infection was associated with the duration of the intervention and was higher for procedures CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term. Infections of implantable devices are associated with a poor prognosis, even in an excess mortality. It has been shown that the majority of infections may be linked to local contamination during surgery reinforcing the idea that prevention is mainly based on local measures and the reduction of operating time.
The aim of the present study is to compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.
The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.
The goal of the pilot study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce pacemaker infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This pilot study will provide feasibility information for a larger cluster randomized crossover design (CRCD).
The purpose of this study is to compare the two options for management of ICDs (internal cardioverter defibrillators) in patients undergoing procedures with electrocautery: (1) programming ICD therapies "off," or (2) use of a magnet to suspend ICD therapies By comparing these two techniques the investigators hope to demonstrate the efficiency of using an ICD magnet protocol during perioperative management of patients undergoing electrocautery procedures. Secondary purposes are to gain further information on health care resources, incidence of EMI, handoff communications and to document lack of adverse events in either group. Primary objective will be: ICD therapy "off times" will be less with the use of a magnet protocol compared to an "off-on" protocol. Secondary objectives will be: (1) Healthcare resources (time and costs of skilled personnel) will be less using a magnet protocol compared to an off-on protocol, and (2) there will be no difference between adverse events in the magnet protocol compared to an off-on protocol. The incidence of EMI and number of handoff communications will be documented. The investigators hypothesis is that the number of minutes with ICD therapies "off" will be significantly less with magnet use. The investigators also expect health care resources to be less with magnet use compared to reprogramming.