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Sudden Cardiac Death clinical trials

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NCT ID: NCT03366181 Completed - Heart Failure Clinical Trials

Anti Arrhythmic Therapies and Sudden Cardiac Deaths

Start date: November 1, 2017
Phase:
Study type: Observational

Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), ST protein, and adiponectin could be used as predictors for the occurrence of malignant ventricular arrhythmias in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention and treated by catheter ablation for ventricular arrhythmias.

NCT ID: NCT03319160 Completed - Clinical trials for Sudden Cardiac Death

LifeVest Safety and Efficacy in Real Life Settings in France

WEARIT France
Start date: February 2, 2017
Phase:
Study type: Observational [Patient Registry]

This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.

NCT ID: NCT03291145 Completed - Clinical trials for Sudden Cardiac Death

Exploring Mechanisms and Morphology of QT Interval Prolongation

TriQarr
Start date: June 27, 2017
Phase: N/A
Study type: Interventional

The projects will try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing". First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.

NCT ID: NCT03248557 Completed - Clinical trials for Sudden Cardiac Death

Prognostic Value of Ventricular Fibrillation Spectral Analysis in Sudden Cardiac Death

AWAKE
Start date: June 2016
Phase:
Study type: Observational

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.

NCT ID: NCT03185832 Completed - Heart Failure Clinical Trials

Heart Failure and Sudden Cardiac Death Japan Registry

HINODE
Start date: July 21, 2017
Phase:
Study type: Observational

The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States. Selected Subject Cohorts: 1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment. 2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment. 3. Selected subject cohort who are clinically expected to require >40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades). 4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P. The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort. The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort. The all-cause mortality will be assessed in the non-implanted subject cohort.

NCT ID: NCT03101787 Completed - Cardiac Arrest Clinical Trials

Early Initiation of Extracorporeal Life Support in Refractory OHCA

INCEPTION
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.

NCT ID: NCT03016754 Completed - Heart Failure Clinical Trials

Heart Failure Optimization Study

HF-Opt
Start date: March 1, 2017
Phase:
Study type: Observational

This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

NCT ID: NCT02923726 Completed - Clinical trials for Sudden Cardiac Death

Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP

APPRAISE ATP
Start date: September 30, 2016
Phase: N/A
Study type: Interventional

The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.

NCT ID: NCT02819973 Completed - Heart Failure Clinical Trials

Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

VIVID
Start date: July 2016
Phase: N/A
Study type: Interventional

VIVID is a prospective, multicenter, randomized clinical trial in African American patients that will to evaluate: (1) the effect of an educational video on knowledge of sudden cardiac death (SCD) and implantable cardioverter defibrillators (ICDs); (2) the effect of an educational video on the decision for ICD implantation, decisional conflict, and receipt of an ICD within 90 days; and 3) the effect of racial concordance between study patients and video participants (health care providers/patients) on the decision for ICD implantation, decisional conflict and ICD receipt within 90 days.

NCT ID: NCT02176174 Completed - Stroke Clinical Trials

Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study

Start date: December 2013
Phase: N/A
Study type: Observational

Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary by ethnic group. However, less is known about differences between ethnic groups and a wider range of cardiovascular diseases. This study will examine differences between ethnic groups (White, Black, South Asian and Mixed/Other) and first lifetime presentation of twelve different cardiovascular diseases. This information may help to predict the onset of cardiovascular diseases and inform disease prevention strategies. The hypothesis is that different ethnic groups have differing associations with the range of cardiovascular diseases studied.