Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias
Sudden Cardiac DeathVentricular Tachycardia2 moreThe purpose of this research study is to examine the effect of cardiac sympathetic denervation (CSD) surgery on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death. Subjects will be asked to participate in this research study if they have recurrent ventricular tachycardia (at least one ICD shock for ventricular tachycardia) and have undergone at least one catheter ablation procedure or have ventricular tachycardia or fibrillation that is not ablatable. The goal of this study is to determine whether cardiac sympathetic denervation can prevent these abnormal heart rhythms from occurring and therefore, prevent, ICD shocks which are not only painful, but have been shown to reduce quality of life and/or lead to depression, particularly in the period immediately after the shock.
Assessment of Combined CCM and ICD Device in HFrEF
Heart FailureHeart Failure With Reduced Ejection Fraction9 moreThe 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.
GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)
Ventricular ArrythmiaVentricular Tachycardia3 moreThis study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.
Epinephrine Dose: Optimal Versus Standard Evaluation Trial
Cardiac ArrestOut-Of-Hospital3 moreThe objective of this randomized controlled trial is to evaluate the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose of epinephrine during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adult out-of-hospital cardiac arrest (OHCA) patients.
Quinidine Versus Verapamil in Short-coupled Idiopathic Ventricular Fibrillation
Short-coupled Idiopathic Ventricular FibrillationShort-coupled idiopathic ventricular fibrillation (IVF) is a rare subtype of idiopathic ventricular fibrillation that is characterized by ventricular fibrillation (VF) or polymorphic ventricular tachycardia (PVT) initiated by a short-coupled premature ventricular contraction (PVC). Although patients are protected from sudden cardiac death by an implantable cardioverter-defibrillator (ICD), additional antiarrhythmic drug therapy is indispensable as recurrent ICD shocks are not uncommon and can negatively affect quality of life. Verapamil and quinidine have been suggested as effective antiarrhythmic drugs, but at present it is unknown whether these drugs reduce the incidence of arrhythmic events. This pilot study will provide insight into the advisability and feasibility of a randomized controlled trial (RCT) and provide data needed to determine the most appropriate design and the sample size.
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
Ventricular ArrythmiaVentricular Tachycardia1 moreSTEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations. The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.
A Danish ICD-study in Patients With Coronary Artery Disease Resuscitated From Ventricular Fibrillation...
Coronary Artery DiseaseAcute Myocardial Infarction4 moreDanICD is a randomized, controlled study to with the aim to assess whether there is a benefit of ICD-implantation in patients with coronary artery disease (including acute myocardial infarction), who survive cardiac arrest due to ventricular fibrillation/sustained ventricular tachycardia and undergo revascularization and with an LVEF above 35%.
Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular...
Hypertrophic CardiomyopathyHypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it. Unfortunately, a small number of people with the condition can suddenly develop a dangerous fast heart beat that can lead to death. There is no cure, but implanting a cardioverter-defibrillator (ICD), which is like a pacemaker can save the life of affected individuals. However, ICD implantation has its own problems, so choosing who gets an ICD is a very important decision. The current approach for recommending people for an ICD has limitations and a better method is needed. Investigators have developed a new technique called the 'Ventricular Conduction Stability' (V-CoS). This involves wearing a special vest which records electrical signals from the heart, and then running on a treadmill. Investigators have used it to identify abnormalities in the hearts of people with (HCM) who have also survived a life-threatening event. This project aims to test new tool against current methods to ascertain which is better at identifying patients who should have an ICD.
Registry of Device Implantation
SyncopeBradycardia4 moreThe implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice. Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy have been developed since 1960s, and the technologies in this field are still progressively developing. Not only these "traditional" implantable devices, there are multiple new devices for cardiac diseases, such as implantable loop recorder, vagal nerve stimulator and barostimulator. The aim of this registry is to demonstrate the efficacy and the safety of standard device implantation procedures and to evaluate/ identify specific factors, including clinical characteristics, laboratory data and procedural data, which predict the prognosis/complication of the patients. These identification will result in further improvement of patients' care.
Vfib by ECG or Echo During Cardiac Arrest
Cardiac ArrestThe goal of this study is to measure survival rates associated with patients presenting in cardiac arrest based on their electrocardiographic rhythm and their echocardiographic rhythm. Electrocardiographic rhythm is defined as the rhythm on the ECG and echocardiographic rhythm is the rhythm visualized on bedside ultrasound. Specifically, we will categorize patients based on identical rhythms and dichotomous rhythms with an interest in outcomes in the patient group where their echocardiographic and electrographic rhythms do not match. This is important as current ACLS protocols use electrocardiographic rhythms to determine therapy but limited research implies that therapeutic decisions based on echocardiographic rhythm may produce increased survival. This study will occur during emergency department resuscitation of patients presenting in cardiac arrest. Patients presenting to the emergency department after cardiac arrest will undergo standard resuscitation based on ACLS protocols. Ultrasound imaging will be performed as soon as possible after the patient arrives and digitally recorded, as is currently the standard of care at the institute. Simultaneous recording of the ECG rhythm strip will occur as well. This will be repeated for as many pauses in CPR as is warranted. Each site will record data based on the Utstein nomenclature including patient demographics, arrest details and survival outcomes. Ultrasound images and ECG recordings will be de-identified and submitted to a central database. Data will be uploaded into a centralized database. Statistical analysis will analyze outcomes based on echocardiographic and sonographic findings. Our aim is to measure the survival benefit of treating out of hospital cardiac arrest using echocardiographic rhythm instead of electrocardiographic rhythm.