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22 active trials for Ventricular Fibrillation

SD01 Registry (SD01 ICD Lead)

This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.

Start: March 2014

SD01 Master Study (Safety and Efficacy Study)

The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

Start: May 2013

Acute Feasibility Investigation of a New S-ICD Electrode

This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD

Start: November 2018

DOuble SEquential External Defibrillation for Refractory VF

Despite significant advances in resuscitation efforts, there are some patients who remain in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double sequential external defibrillation (DSED) and vector change defibrillation have been proposed as viable options for patients in refractory VF. This cluster randomized trial will compare (1) continued resuscitation using standard defibrillation; (2) resuscitation involving DSED; or (3) resuscitation involving vector change defibrillation, in patients presenting with refractory VF during out-of-hospital cardiac arrest. The results of this study will provide high level evidence of the impact of both DSED and vector change defibrillation on ROSC and patient survival after OHCA.

Start: September 2019

Cardiac Rehab Retrospective Review (CR3)

All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients. Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.

Start: February 2021

Prognostic Value of Ventricular Fibrillation Spectral Analysis in Sudden Cardiac Death

Ventricular fibrillation (VF)-related sudden cardiac death (SCD) is a leading cause of mortality. Patients may survive with neurological damage despite state-of-the-art treatment. Current biological and imaging parameters show significant limitations on early predicting cerebral performance at hospital admission. A spectral-based model was recently suggested to correlate time-dependent VF spectral changes with acute cerebral injury in comatose survivors after cardiac arrest, which opens the possibility to implement early prognostic tools in clinical practice. The AWAKE trial is an investigator-initiated, multicenter, observational trial aiming to validate a spectral-based model to early predict cerebral performance and survival in resuscitated comatose survivors admitted to specialized intensive care units. The primary clinical outcome is favorable neurological performance (FNP) during hospitalization. Patients will be categorized into 4 subsets of NP according to the risk score obtained from the predictive model. The secondary clinical outcomes are survival to hospital discharge, and FNP and survival after 6 months of follow-up. Model-derived categorization will be compared with clinical outcomes to assess model sensitivity, specificity and accuracy. Eligible patients will be included prospectively and retrospectively, using an electronic Case Report Form to enter data from medical records and in-person interviews. Patients will be divided into: study group (predictive data required) including comatose (Glasgow Coma Scale -GCS- ?8) survivors undergoing temperature control after return of spontaneous circulation (RoSC), and control group including patients who regain consciousness (GCS=15) after RoSC. VF tracings prior to the first DC shock will be digitized and analyzed to derive spectral data and risk scores.

Start: June 2016

Epinephrine Dose: Optimal Versus Standard Evaluation Trial

The 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.

Start: October 2021

Unpinning Termination Therapy for VT/VF

This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is hypothesized to be effective in stopping these dangerous heart rhythms at lower voltages and energy than current defibrillators. Consequently, UPT may improve survival, reduce patient pain from shocks, and lead to longer lasting and smaller implantable defibrillators.

Start: July 2019

Cardiopulmonary Resuscitation Performance of Professional Rescuers With a New Defibrillation Algorithm

In the Paris (France) Medical Emergency system, in the early phase of Out-of-hospital Cardiac Arrest (OHCA), the treatment of a Ventricular Fibrillation (VF) consists of delivering an External Electric Shock (EES) by a rescuer with the use of an Automated External Defibrillator (AED). This latter realizes a cardiac rhythm analysis every two minutes. This analysis requires that chest compressions (CC) be interrupted for a while. However, CC interruptions are potentially harmful due to the brain, and heart perfusions decrease. On the other hand, the recurrence of VF occurs mostly during the first minute after the shock, whereas the delay between 2 rhythm analysis is 2 minutes. The consequence is excessive time spent in VF, which is deleterious in terms of coronary and cerebral perfusion. The investigator implements a new AED algorithm whose operating principle is as follows. One minute after an EES administration, the AED realizes a cardiac rhythm analysis during which the rescuers do not need to interrupt the chest compressions (CC): this is called the rhythm analysis " in presence of CC" The detection of a VF " in presence of CC " needs to be confirmed, " in absence of CC " The CC's are therefore interrupted for new rhythm analysis. Once the presence of VF is approved, the AED proposes a shock to be administred The aim of the study Study Design: This is a prospective observational study. The eligibility criteria are as follows: Patients in Out-Of-Hospital Cardiac Arrest. Basic Life support care with an AED. The primary endpoint is the " chest-compression fraction (CCF) " that represents the CPR-time performance during the ten first minutes of BLS care ( or < 10 min in case of Return Of Spontaneus Circulation (ROSC))

Start: January 2021

A Danish ICD-study in Patients With Coronary Artery Disease Resuscitated From Ventricular Fibrillation

DanICD 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%.

Start: October 2020

Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 )

To establish whether a pre-hospital advanced physician/ paramedic cardiac arrest team that is ECMO capable can establish ECMO flow within 30 minutes of collapse. The Sub30 study will investigate the technical and logistical feasibility of instituting pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) within 30 minutes of collapse for selected patients (n=6) in a geographical sector of Greater London. It will achieve this through a unique collaboration between the primary emergency dispatch and response services (London Ambulance Service NHS Trust, LAS), pre-hospital practitioners (LAS and London Air Ambulance) and clinicians in ECMO (Barts Health NHS Trust).

Start: September 2019

Defining the Electrocardiographic Effect of Propofol on the Ajmaline Provocation Drug Challenge: A Prospective Trial

Background: Brugada Syndrome is an inherited channelopathy associated with risk of ventricular fibrillation and sudden cardiac death in a structurally normal heart. The diagnosis is based on the characteristic electrocardiographic pattern (coved type STsegment elevation, 2mm followed by a negative T-wave in one or more of the right precordial leads V1 to V2), noted spontaneously or upon administration of a sodiumchannel blocker, such as Ajmaline. The majority of adults screened for Brugada Syndrome, undergo the Ajmaline provocation-test awake. Ajmaline is therefore injected continuously, with incremental steps through an intravenous placed catheter, according to cardiological protocols. In a subpopulation of anxious adults, or when another electrophysiological procedure is required at the same time, sedation or general anaesthesia is provided. Similarly, in the paediatric population, it is common practice to perform the challenge test under sedation. Based on the sodium channel blocking properties of propofol, it is not unthinkable that anaesthetic agents might interact with the pharmacodynamic or pharmacokinetic effects of Ajmaline on the myocardial sodium channels. Existence of such interaction would implicate altered diagnostic value of the Ajmaline-provocation-test for patients that undergo the challenge under general anaesthesia. Objective: The goal of this study is to evaluate if the Ajmaline-provocation-test results in altered electrocardiographic effects when performed under general anaesthesia with propofol. Study-design: A prospective observational study. Study population: Patients are eligible for inclusion if they have been diagnosed with Brugada Syndrome, are American Society of Anaesthesiologists (ASA) 2 - 4, older than 18 years and are scheduled for epicardial ablation. Exclusion criteria are known allergy for propofol, a body mass index (BMI) above 35 for female and 42 for male patients, obstetric patients, critical illness, conditions that exclude continuous propofol infusion due to higher risk for propofol infusion syndrome (PRIS), such as mitochondrial disease, fatty acid oxidation disorder, co-enzyme Q deficiency and any other condition that renders the patient unfit for elective surgery. Intervention: This study is prospective, observational. Main study parameters/endpoints: The primary endpoints are changes in the ST-, Jp-, QRS-, T(p-e)-segments and T(p-e)/QT -ratio changes during steady-state anaesthesia. The secondary endpoint is the occurrence of de novo arrhythmias. Nature and extent of the burden and risks associated with participation: This is an observational study; therefore, the risks associated are no other than those associated with the intervention itself. No additional blood-samples, tests or consults are necessitated during participation; therefore, no extra burden is associated.

Start: November 2020

Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Cardiopulmonary Resuscitation

Time-limited adaptive responses of thyroid function are common in the critically ill. About 70% of all patients treated on intensive care units develop a so-called non-thyroidal illness syndrome (NTIS) or TACITUS (thyroid allostasis in critical illness, tumours, uraemia and starvation), which is marked by low serum concentrations of the thyroid hormone T3 and other adaptive reactions of thyroid homeostasis. Occasionally, temporarily elevated concentrations of thyrotropin (TSH) and peripheral thyroid hormones are to be observed, especially after cardiopulmonary resuscitation (CPR). However, the available evidence is limited, although abnormal concentrations of thyroid hormones after CPR have occasionally been reported. Aim of the planned study is to investigate the thyrotropic (i.e. thyroid-controlling) partial function of the anterior pituitary lobe immediately after CPR. It is intended to evaluate statistical measures of TSH concentration and peripheral thyroid hormones in de-identified datasets (protocol A). Additionally, a prospective sub-study (protocol B) aims at a more precise description of pituitary and thyroid responses by means of serial investigations in routine serum samples, both immediately after CPR and during the course of ongoing treatment. This includes the evaluation of additional possible predictors, too. Primary endpoint of the study is changed TSH concentration immediately after CPR compared to the TSH value 24 hours later. Secondary endpoint is the relation between thyroid-controlling pituitary function and mortality. A high proportion of patients undergoing CPR will eventually receive iodinated radiocontrast media (e.g. for computed tomography or coronary angiography). This is one of the reasons why early identifying subjects at high risk for possible iodine-induced thyrotoxicosis is important. Increased oxygen consumption of the heart in hyperthyroidism is one of the reasons for high mortality in thyrotoxicosis. Therefore, accurate diagnosis of alterations in the hypothalamus-pituitary-thyroid (HPT) axis is of paramount importance.

Start: November 2020

Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with (increased risk of) ventricular tachyarrhythmias (VTA) and sudden cardiac arrest, and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Moreover, clinical data of subjects will be gathered. By combining the data from the data gathering and the results of ECGI, the investigators hope to increase mechanistic understanding of and risk stratification for VTAs. The investigators aim to be able to identify patients at risk of an arrhythmic event, and aim for better treatment strategies in the future.

Start: June 2020

Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions

The "Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions (RACE-IT)" represents a mono-centric registry of patients being hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation) and sudden cardiac death (SCD). Detailed findings of patients' clinical outcome regarding mortality and co-morbidities related to the presence of invasive diagnostics or therapies including coronary angiography, percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be documented. Patients will be included when being hospitalized from the year 2004 until today.

Start: April 2016

Gut Microbiome and Ventricular Arrhythmias

Ventricular tachycardia and ventricular fibrillation (VT/VF) are the most common causes of sudden cardiac death in patients with diseased hearts. The factors contributing to these deadly arrhythmias are not well understood. The presence of a wide variety of microbial flora in the human GI tract, particularly colon has been well recognized for a long time. There are also emerging links showing the effect of an intact gut microbiome having effects on left ventricular remodeling after myocardial infarction and hypertension. Gut microbiota has also been associated with outcomes in atrial fibrillation. There is little available in current literature showing a relationship between gut microbiome characteristics and ventricular arrhythmia burden. The gut microbiome has particularly strong interactions with neuroendocrine and immunologic mediators and has effects on the modulation of the autonomic nervous system. These systems are also hypothesized to influence ventricular arrhythmias. We propose to study the relation and interaction between gut microbiome and ventricular arrhythmogenesis.

Start: August 2020

Austrian Wearable Cardioverter Defibrillator Registry

Background: The wearable cardioverter defibrillator (WCD) is an established treatment option for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF), either in whom this risk may only be temporarily present, or in patients at high risk for sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator (ICD is currently not possible for other reasons (infection, recent MI <40days, recent PCI/CABG < 3months etc.). Methods: Comprehensive registry including all patients in Austria who received a WCD in 2010-2016.

Start: November 2014

Registry of Device Implantation

The 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.

Start: January 2011

Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation.

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with unexplained polymorphic ventricular tachycardia (VT) and/or ventricular fibrillation (VF), in patients with specific genetic mutations regarding sudden cardiac death or sudden cardiac arrest, in their family members and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Also a National Dutch registry for patients with unexplained polymorphic VT and/or VF and their family members will be created. By combining the data from the registry and the results of ECGI, The investigators hope to identity risk markers for patients at higher risk for apparently idiopathic ventricular fibrillation, and use these for an adapted flow chart for the 'general'population of patients at risk for unexplained polymorphic VT and/or VF. The investigators aim to be able to identify patients before the first arrhythmic event, and aim for better treatment strategies in the future.

Start: April 2019

Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response

Amiodarone is considered the medicine of choice in heart rate control in critically ill patients with atrial fibrillation with high ventricular response. However, a recent retrospective study showed a greater number of events in critical patients in whom there was an attempt to control versus in which there was no. Therefore, the prospective and randomized comparative use of amiodarone in this group of patients has not yet been described. The aim of this study was to evaluate the safety of the use of amiodarone (restricted group) versus placebo (liberal group) in heart rate control in atrial fibrillation with high ventricular response in patients with sepsis and vasopressor cardiovascular dysfunction. For this, a unicentric, randomized, blind and prospective study will be performed, in which the restrictive versus liberal strategy is performed in a comparative way. Hospital data (test results, medical evolutions complications) of patients will be analyzed to calculate safety and effectiveness. Expected results: The liberal strategy is superior to the restrictive strategy and causes fewer adverse events.

Start: December 2018