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Death, Sudden, Cardiac clinical trials

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NCT ID: NCT00619593 Completed - Clinical trials for Sudden Cardiac Death

Survival of Patients With Primary Prophylactic ICD Indication

SPIRIT-ICD
Start date: February 2008
Phase: Phase 4
Study type: Interventional

The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients. This trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.

NCT ID: NCT00614718 Completed - Clinical trials for Ventricular Fibrillation

Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

Start date: January 1993
Phase: N/A
Study type: Observational

Comparison of two different approaches to address the problem of malfunctioning ICD-leads. These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if required) (Pace/Sense) and a second part that is used to deliver therapy is needed (Shock-coil). The two approaches compared are: Replacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.

NCT ID: NCT00586378 Completed - Clinical trials for Sudden Cardiac Death

Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Post-Ovatio
Start date: April 2006
Phase: Phase 3
Study type: Interventional

The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs

NCT ID: NCT00580775 Completed - Menopausal Women Clinical Trials

Study of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death

KEEPS
Start date: September 2005
Phase: N/A
Study type: Observational

As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180), the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on autonomic function and repolarization; both measured non-invasively via holter monitoring.

NCT ID: NCT00560768 Completed - Clinical trials for Sudden Cardiac Death

Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications

Prediction
Start date: December 2007
Phase: Phase 4
Study type: Interventional

The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.

NCT ID: NCT00534300 Completed - Clinical trials for Ventricular Tachycardia

Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker

Start date: October 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil. This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker. The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce. In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol. The main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.

NCT ID: NCT00478933 Completed - Atrial Fibrillation Clinical Trials

DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

DISCOVERY
Start date: February 2007
Phase: N/A
Study type: Interventional

To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia. To evaluate the influence of ICD-based diagnostic information on the long term treatment and management of primary prevention ICD-patients.

NCT ID: NCT00439790 Completed - Heart Failure Clinical Trials

Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients

Start date: January 2007
Phase: N/A
Study type: Observational

The aim of this study is to analyze whether the sympathetic tone, measured indirectly and directly by muscle sympathetic nerve activity recording, is elevated in patients with heart failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD) compared to heart failure patients not receiving a shock from their ICD. All parameters measured in this study will be used to build a risk algorithm able to identify heart failure patients at high risk for sudden cardiac death who could receive an ICD.

NCT ID: NCT00399503 Completed - Clinical trials for Myocardial Infarction

Assessment of Noninvasive Methods to Identify Patients at Risk of Serious Arrhythmias After a Heart Attack

Start date: September 2001
Phase: N/A
Study type: Observational

This study evaluates the usefulness of noninvasive tests of the structure of the heart and the nervous system controlling the heart. It will assess whether combining tests that evaluate heart structure with others that measure the nervous system controlling the heart will identify most patients who develop serious heart rhythm problems after a heart attack.

NCT ID: NCT00382928 Completed - Clinical trials for Ventricular Fibrillation

Automatic External Defibrillation Monitoring in Cardiac Arrest

Start date: October 2006
Phase: Phase 1
Study type: Interventional

We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments being constant including cardiopulmonary resuscitation. We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic technology used in AECDs will further increase the rate of survival in patients with cardiac arrest through rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation initiated by healthcare providers.