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Death, Sudden, Cardiac clinical trials

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NCT ID: NCT01665755 Completed - Clinical trials for Ventricular Tachycardia

To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients

Start date: January 2016
Phase: N/A
Study type: Interventional

In this study, we are comparing the difference in outcomes between patients who were given shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before CPR is started. The study population will be all cardiac arrest patients attended by the staff of the Emergency Department who fulfil the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest compressions are delivered by an automated device) is prepared. Mechanical CPR should be started as soon as possible (<1 minute). If patients are eligible to be shocked, they will receive shocks either during upstroke of CPR or before CPR is started. Thus the purpose of this study is to answer the question whether are there improvement in survival between when shocks are given during upstroke and before CPR is started.

NCT ID: NCT01638897 Completed - Heart Failure Clinical Trials

DF4 Connector System Post-Approval Study

Start date: January 2012
Phase:
Study type: Observational

The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.

NCT ID: NCT01599065 Completed - Heart Failure Clinical Trials

Comparison of a MAGNET Protocol Versus "off-on" Protocol for Patients With Implantable Cardioverter Defibrillators

MAGNET
Start date: December 2011
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01596595 Completed - Clinical trials for Primary Prevention of Sudden Cardiac Arrest

Longitudinal Surveillance Study of the 4-SITE Lead/Header System

LSS of 4-SITE
Start date: April 4, 2013
Phase:
Study type: Observational

Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.

NCT ID: NCT01594112 Completed - Atrial Fibrillation Clinical Trials

Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.

THORN
Start date: March 15, 2012
Phase: N/A
Study type: Observational

The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single, dual, or triple chamber). The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate therapies (IT), and to take preventive actions in order to reduce the burden of these inappropriate therapies. THORN is an observational epidemiologic, prospective and multicenter registry. The primary objective is to measure the relative proportion of patients experiencing at least one inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD patients.

NCT ID: NCT01521208 Recruiting - Clinical trials for Sudden Cardiac Arrest

LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial

LUCAT
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The goal of this study is to show the superiority in survival at hospital admittance and in neurological outcome on hospital discharge of continuous mechanical chest compression using LUCAS device versus manual chest compressions in patients who suffered an out-of-hospital cardiac arrest.

NCT ID: NCT01448005 Terminated - Myocardial Ischemia Clinical Trials

LifeVest Post-CABG Registry

Start date: February 2011
Phase: N/A
Study type: Observational

This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.

NCT ID: NCT01378572 Recruiting - Clinical trials for Dilated Cardiomyopathy

Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrillators in Dilated Cardiomyopathy

EMOSIDD
Start date: November 2009
Phase: N/A
Study type: Observational

With the present study the investigators intend to identify the morphologic and electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of sudden cardiac death. Moreover, the investigators also aim to identify if there is any electrophysiological substrate modification at the time of the first arrhythmic event in these patients. To this aim, the investigators will prospectively correlate electroanatomic mapping and cardiac magnetic resonance findings with arrhythmic events, in order to identify substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy, who are therefore more likely to benefit from a defibrillator implantation. Furthermore, electroanatomic mapping will be repeated at the time of the first arrhythmic event and compared with that at baseline, in order to evaluate any electrophysiological substrate changes.

NCT ID: NCT01377337 Not yet recruiting - Clinical trials for Sudden Cardiac Arrest

Sodium Bicarbonate in Cardiopulmonary Resuscitation

SB CAT
Start date: December 2011
Phase: Phase 4
Study type: Interventional

Out-of-hospital cardiac arrests (OHCA) account for over 60% of deaths from coronary artery disease. The annual incidence of OHCA treated by Emergency Medical Systems (EMS) is 41-89 per 100,000 population. Outcome of OHCA and cardiopulmonary resuscitation (CPR) is very poor: Less than 1/3 of the victims regain spontaneous circulation (ROSC), 40-60% of those achieving ROSC suffer significant neurological disability due to brain hypoxia and only 1.7-6.4% are discharged from the hospital. In order to minimize hypoxia time, the primary goal of CPR is to achieve return of spontaneous circulation (ROSC) as fast as possible. Metabolic (lactic) acidosis develops rapidly during CA and is considered detrimental to CPR outcome. Sodium bicarbonate (SB), a generic, commonly used acid buffer, was subjected only to a single, small, prospective controlled trial that found a trend towards improved outcome in prolonged OHCA and CPR. Another study indicated that EMS's that used SB early and often during CPR had significantly higher ROSC rates and better long-term outcome compared with EMS's that used SB more seldom and administered it late in the course of CPR. Aim of the Study: To determine whether early administration of SB during OHCA and CPR improves short-term CPR outcome.

NCT ID: NCT01326624 Completed - Heart Failure Clinical Trials

Study of the Wearable Defibrillator in Heart-Failure Patients

SWIFT
Start date: March 2011
Phase: N/A
Study type: Observational

The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not able to receive the device due to their condition.