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Sudden Cardiac Arrest clinical trials

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NCT ID: NCT05855135 Recruiting - Heart Failure Clinical Trials

Assessment of Combined CCM and ICD Device in HFrEF

INTEGRA-D
Start date: May 17, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

NCT ID: NCT05799833 Recruiting - Clinical trials for Sudden Cardiac Death

Low QRS Voltages in Young Healthy Individuals and Athletes

Start date: October 9, 2023
Phase:
Study type: Observational

There is some limited evidence that reduced size of electrical complexes/traces of the heart on the electrocardiogram (ECG) may be associated with scarring in the heart muscle, which may predispose to serious life-threatening electrical abnormalities and sudden cardiac death (SCD). There is no current guidance on how young individuals and athletes with reduced ECG traces should be managed. Therefore, correct interpretation of this ECG finding is crucial for identifying athletes with disease and at risk of SCD. Some athletes experience SCD despite normal standard cardiac tests. The investigators, therefore, propose to study young healthy individuals and young athletes using cardiovascular MRI, cardiopulmonary exercise testing, 24 hour ECG monitoring and genetic analysis to determine the significance of reduced ECG traces and possibly revise current international sports recommendations.

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: 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: 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.

NCT ID: NCT04250857 Recruiting - Clinical trials for Sudden Cardiac Arrest

HeartStart FRx Defibrillator Event Registry

Start date: November 4, 2019
Phase:
Study type: Observational [Patient Registry]

This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.

NCT ID: NCT03826524 Recruiting - Clinical trials for Ventricular Fibrillation

Epinephrine Dose: Optimal Versus Standard Evaluation Trial

EpiDOSE
Start date: May 24, 2023
Phase: Phase 4
Study type: Interventional

The objective of this randomized controlled trial is to evaluate the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose of epinephrine during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adult out-of-hospital cardiac arrest (OHCA) patients.

NCT ID: NCT03049254 Recruiting - Clinical trials for Cardiovascular Diseases

Mayo AVC Registry and Biobank

Start date: February 9, 2018
Phase:
Study type: Observational

Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death. The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples. Objectives of the study: 1. Discover new genes or altered genes (variants) which cause AVC 2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation) 3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data. 4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies

NCT ID: NCT02874469 Recruiting - Clinical trials for Sudden Cardiac Arrest

Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death

COREABOR
Start date: December 31, 2014
Phase: N/A
Study type: Interventional

Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year. Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life. Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context. Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death. Secondary objectives - To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death - To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities - To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives - To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary) - Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology - Qualitative evaluation of the diary - Evaluation of the paramedical feeling before and after the diary input in practice

NCT ID: NCT02816047 Recruiting - Heart Failure Clinical Trials

Austrian Wearable Cardioverter Defibrillator Registry

Start date: November 2014
Phase:
Study type: Observational

Background: The wearable cardioverter defibrillator (WCD) is an established treatment option for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF), either in whom this risk may only be temporarily present, or in patients at high risk for sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator (ICD is currently not possible for other reasons (infection, recent MI <40days, recent PCI/CABG < 3months etc.). Methods: Comprehensive registry including all patients in Austria who received a WCD in 2010-2016.