Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model...
Ventricular ArrhythmiasPeople who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device. A feature of this device allows it to send small, painless electrical impulses (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. This device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium). This study is now complete and the device has since been approved by the FDA.
Cardiac Arrhythmia Pilot Study (CAPS)
ArrhythmiaCardiovascular Diseases2 moreTo compare the effectiveness of various drugs and drug combinations in suppressing complex ventricular arrhythmias, and to evaluate their safety.
Cardiac Rehabilitation for Young People
Congenital Heart DiseaseCardiomyopathies4 moreHeart problems are amongst the most common physical illnesses in children and young people (CYP). They can be present from birth or develop as CYP get older and are linked to increased physical and psychological difficulties overprotection from caregivers and healthcare providers and reduced quality of life. While adults are offered exercise classes and lifestyle advice after a heart problem, CYP with heart problems are not. Improving health behaviours in people with heart problems is vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes). Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also important to support their mental health. One way to do this is to develop and test the acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of exercise with mental health support for CYP. The aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for CYP.
Effects of Osteopathic Manipulative Therapy on Arrhythmias
Cardiac ArrhythmiaThe study focuses on patients who have already been diagnosed with an arrhythmia. This is a randomized control trial that will use measurements from the implanted devices to quantify changes in the number of cardiac events experienced. Subjects will present to the Long Island Heart Rhythm Clinic (LIHRC) at the New York Institute of Technology (NYIT) Academic Health Care Center for their scheduled appointment with Dr. Cohen. These patients are generally coming in for their electrophysiology cardiology checkup, postsurgical visit, or consultation concerning their cardiac health. Once confirmed the patients meet the inclusion criteria, they will be informed about this proposed study and asked if they would like to participate. They will then be consented and randomized according to the randomization procedure outlined below. Once enrolled, the patients will complete the study as outlined in the procedures below. They will have a baseline EKG taken, and then proceed to either Osteopathic manipulative medicine (OMM) treatment or control somatic dysfunction (SD) evaluation. The investigators will then analyze the CareLink data, or the web-based management service for the respective device, to quantify the effects the OMM or control SD evaluation had on any arrhythmia events. All investigators delivering OMM will be neuromuscular medicine/osteopathic manipulative medicine (NMM/OMM) board certified attending physicians and trained in the specific techniques that have been associated with arrhythmia SDs and treatment modalities to have consistency when treating subjects. Subject confidentiality will be maintained throughout the process as delineated in Question 5 of the protocol document.
Comparison of Efficacy and Safety of Two Biphasic Defibrillators in Cardioversion of Atrial Fibrillation...
Atrial FibrillationArrythmia1 moreBackground: Biphasic truncated exponential (BTE) waveforms are standard for cardiac defibrillation and synchronized cardioversion up to date. BTE waveforms differ by design characteristics and technologies for pulse commutation (rectilinear, standard truncated exponential, pulsed). Clinical evaluation of BTE waveforms can be planned during cardioversion (CVS) as a well-established procedure of atrial fibrillation patients who are able to give consent and also present a more controlled population. Scarce studies have been found to present the relative efficacy and safety of different BTE waveforms during CVS. The validity of significantly deviating results of the pulsed waveform in one CVS study is questionable. Objective: To compare the CVS efficacy and safety two different biphasic defibrillators - a standard truncated exponential waveform and a pulsed biphasic waveform. Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit (ICCU), Cardiology Clinic, University National Heart Hospital (NHH), Sofia, Bulgaria, underwent the pre-CVS medical exams and check for eligibility. All eligible patients will sign a written informed consent prior to the CVS and will receive the standard hospital procedures during CVS, accepted in the NHH, and approved by the NHH Local Ethic Committee. Atrial fibrillation patients will be alternatively randomized to CVS using one of the two defibrillators, following the same energy selection protocol in both defibrillators. The statistical power analysis will consider a non-inferiority comparison between the cumulative energy actually delivered by both defibrillators. The secondary CVS outcome measures are: the cumulative success rate (measured at 1 minute post-shock) and number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NHH Local Ethic Committee). Heart rhythm will be monitoring in continuously recorded peripheral ECG. The secondary CVS safety outcome measures: Biochemical markers for myocardial necrosis (high sensitive troponin I - hsTnI, creatine kinase MB fraction - CK-MB) will be evaluated on blood samples taken before and 12 hours after cardioversion; ST-segment changes will be measured in lead II (baseline and 10 s post-shock) and 12-lead ECG; Complications after cardioversion will be measured during 2 hours follow-up period in the ICCU.
Effect of His Bundle Pacing in Treatment of Slow Arrhythmia on Function of Left Atrial and Ventricle...
Slow ArrhythmiaHis Bundle Pacing1 moreBradyarrhythmia is one of the common diseases. Also, bradyarrhythmia could result in syncope, clinic convulsion, shock, sudden death and so on, which could influence people's life quality severely. Artificial pacemaker is the only way that can cure bradyarrhythmia. However, traditional right ventricular apical pacing, because its electric stimulation is mostly different of the physiological one, could lead to ventricular thick inhomogeneously. At the same time, traditional right ventricular apical pacing also could result in cardiac arrhythmia and fibrosis, dyssynchrony of the ventricles, which can increase the volume of mitral regurgitation. Besides, cardiac resynchronization therapy (CRT), which aims to cure chronic heart failure, is also unsatisfactory. On the contrary, the electric stimulation of his bundle pacing (HBP) is the same as the physiological one, which produces a relatively normal electrical stimulation and synchrony in systolic velocities in ventricular. Thus, HBP could produce a better haemodynamic effect, which is the hotspot in pace-making area recently. The purpose of this study is to conduct a comparison in patients' cardiac function, ECG, and pacemakers' threshold value, time limit and so on among dual chamber pacemaker, and HBP.
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation:...
ArrhythmiasCardiac5 moreSingle center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable cardioverter-defibrillator implantations.
Propafenone Versus Amiodarone in Septic Shock
Supraventricular ArrhythmiaSeptic ShockArrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.
Identification for the Treatment of Complex Arrhythmias
ArrhythmiasThe primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.
Observation of ImageReady™ MR Conditional Defibrillation System in China
ArrhythmiaTo observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.