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Death, Sudden, Cardiac clinical trials

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NCT ID: NCT05159791 Recruiting - Myocardial Ischemia Clinical Trials

New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.

NECESSARY
Start date: November 23, 2021
Phase: N/A
Study type: Interventional

Anomalous Aortic Origin of the Coronary Arteries (AAOCA) is a rare congenital disease that may cause sudden death in young subjects. Frequently the first and only presentation is with an acute event (such as myocardial infarction or sudden cardiac deaths) during physical effort. Not only symptoms are often absent, but also provocative tests fail to induce ischemia or related signs, showing in most patients negative results. For these limitations, the decision to undergo corrective surgery is based on the morphologic characteristics without the support of a functional evaluation. The study focused on developing a personalized ischemic risk assessment with the aid of fluid dynamic simulations. The simulation system integrate clinical data from different diagnostic sources and integrate them with coronary blood flow evaluation at rest and during simulated physical effort.

NCT ID: NCT05140343 Recruiting - Clinical trials for Congenital Heart Disease

Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children

Start date: April 7, 2021
Phase: N/A
Study type: Interventional

The objective of this project is to evaluate the capability of a specific mobile electrocardiogram monitoring of detecting arrhythmic events in children with history of palpitation and or syncope. We will compare this approach with the standard approach of clinical follow-up plus 24-hour Holter ECG monitoring in terms of acceptability and ability to identify significant arrhythmias.

NCT ID: NCT05135403 Recruiting - Clinical trials for Sudden Cardiac Arrest

ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

ACE-PAS
Start date: November 20, 2021
Phase:
Study type: Observational [Patient Registry]

Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.

NCT ID: NCT04856267 Recruiting - Clinical trials for Sudden Cardiac Death

Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders

EXACLIBUR
Start date: May 27, 2021
Phase:
Study type: Observational

The overall aim of this study is to improve our understanding of the effects of the build-up of amyloid deposits in the heart, in particular, our understanding of the risk of abnormal heart beats, or rhythms, associated with people with cardiac (heart) amyloidosis. Symptoms such as palpitations (fast, strong or irregular heart beat) and blackouts are common in people with cardiac amyloidosis, but there is not enough information on what causes this. At present, there is also not enough information on when they occur, how often they happen, and which patients are at risk of having serious, life-threatening types of abnormal heart rhythms. Some of these abnormal heart rhythms can be treated with medicine; others need electronic devices (e.g. pacemakers) implanted or inserted in the heart to prevent serious harm. The information on when is the best time to implant these life-saving devices remains limited. In this study, a small device known as an implantable loop recorder (ILR) will be implanted under the skin on the chest wall to continuously monitor participants' heart rhythm. This will help us answer some of the questions about what causes the abnormal heart rhythms, when they happen, and which patients are particularly likely to have them. Furthermore, it may help us to identify earlier, rather than later, those who are at risk of developing abnormal heart rhythms. This may lead to improvements in the care of people with cardiac amyloidosis in the future. Participants may not directly benefit from taking part in this study; however, there is a chance that the ILR may reveal heart rhythm abnormalities in some participants which might not be picked up otherwise, and so may lead to a change in their treatment.

NCT ID: NCT04840797 Recruiting - Clinical trials for Sudden Cardiac Arrest

HeartStart HS1 Defibrillator* Event Registry

Start date: February 25, 2021
Phase:
Study type: Observational [Patient Registry]

A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) & HeartStart Home (Model M5068A) Defibrillator device data.

NCT ID: NCT04675073 Recruiting - Clinical trials for Myocardial Infarction

Preventive VT Substrate Ablation in Ischemic Heart Disease

PREVENT-VT
Start date: June 1, 2021
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.

NCT ID: NCT04637230 Recruiting - Atrial Fibrillation Clinical Trials

Prevention of Stroke and Sudden Cardiac Death by Recording of 1-Channel Electrocardiograms

PRICE
Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

Single-channel electrocardiograms (lead I of 12-lead surface ECG; 30 seconds) will be collected from subjects/patients at 11 clinical centers in Germany to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms. Heart rhythms of interest are normal sinus rhythm (SR), atrial fibrillation (AF), atrial premature beats (APBs), ventricular premature beats (VPBs), and nonsustained ventricular tachycardia (VT). Per diagnosis, 20,000 ECGs are required, for a total of 100,000 ECGs to be obtained from approximately 10,000 subjects/patients.

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: NCT04575103 Recruiting - Arrythmia Clinical Trials

Monitoring of Arrhythmias in Patients Treated With Antipsychotics

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

Antipsychotics may be associated to life-threatening arrhythmias and sudden cardiac death. This is the fist study to estimated the arrhythmic burden using long-term monitoring by implantable loop recorder in patients treated with antipsychotics.

NCT ID: NCT04493970 Recruiting - Clinical trials for Sudden Cardiac Arrest

HS Students Mandatory Universal Student Instruction in CPR Appraised Learning- Is the Mandate Working?

Start date: February 26, 2021
Phase:
Study type: Observational

This study will help to provide better input to state health and education departments to improve the processes for CPR education. This will also help the EP council explore the opportunities to partner with other professional societies and other stake holders that have interest in this topic. Engagement of private-public partnerships for improving overall CPR education.