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Sudden Cardiac Death clinical trials

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NCT ID: NCT04599439 Recruiting - Clinical trials for Myocardial Infarction

CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

DEVELOP-VT
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical, Barcelona, Spain), with FDA 510(k) Clearance and European Community Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years. In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.

NCT ID: NCT04548804 Enrolling by invitation - Cardiac Arrest Clinical Trials

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

BREACH-ECGI
Start date: June 10, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04540354 Withdrawn - Heart Failure Clinical Trials

Personalised Risk scOre For Implantation of Defibrillators in Patients With Reduced LVEF≤35% and a Low Risk for Sudden Cardiac Death

PROFID-Reduced
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The objective of the study is to demonstrate that in post-MI patients with symptomatic heart failure who receive optimal medical therapy for this condition, and with reduced LVEF ≤ 35% but low risk for SCD according to a personalised risk score, optimal medical therapy without ICD implantation (index group) is not inferior to optimal medical therapy with ICD implantation (control group) with respect to all-cause mortality.

NCT ID: NCT04540289 Withdrawn - Clinical trials for Myocardial Infarction

Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implantation of an ICD (index group) is superior to optimal medical therapy (control group) with respect to all-cause mortality.

NCT ID: NCT04387435 Completed - Epilepsy Clinical Trials

Optimization of VNS in Epileptic Patients to Induce Cardioprotection

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

This study is a non-randomized, prospective study in patients with a diagnosis of epilepsy and previously implanted FDA approved Vagus Nerve Stimulation (VNS) devices. The goal of this clinical investigation is to evaluate the effects of adjusting vagus nerve stimulation parameters to engage cardioprotective effects.

NCT ID: NCT04373876 Recruiting - Cardiac Arrest Clinical Trials

Experience From the Italian S-ICD Registry

ELISIR
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

NCT ID: NCT04368637 Recruiting - Clinical trials for Acute Myocardial Infarction

Acute Cardiovascular Events Triggered by COVID-19-Related Stress

JoCORE
Start date: May 3, 2020
Phase:
Study type: Observational

The current COVID19 pandemic has afflicted almost the whole globe. The stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psychosocial stresses. This study is a cross sectional study that will enroll patients evaluated during the COVID19 pandemic period for acute cardiovascular events.

NCT ID: NCT04127643 Recruiting - Heart Failure Clinical Trials

Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)

Start date: May 10, 2019
Phase:
Study type: Observational

S-ICD avoids the use intravascular leads and their associated risks, has been increasingly used for primary and secondary prevention of sudden death. The long-term safety and feasible of S-ICD system in Asian population with a smaller body size remain unclear. The investigators propose to perform a prospective study in Korean population to investigate the safety and feasibility of S-ICD for primary or secondary prevention of sudden cardiac death.

NCT ID: NCT04101253 Completed - Clinical trials for Sudden Cardiac Death

SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR

SIS
Start date: December 16, 2019
Phase: N/A
Study type: Interventional

S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

NCT ID: NCT04074122 Not yet recruiting - Clinical trials for Ventricular Tachycardia

Electromechanical Profiling of the Long-QT Syndrome (LQTS)

EMLoQ
Start date: January 1, 2020
Phase:
Study type: Observational

High-resolution, non-invasive electromechanical mapping in genotyped long-QT syndrome patients and healthy controls at baseline and during smart provocation.