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Death, Sudden, Cardiac 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: NCT05724121 Recruiting - Clinical trials for Mantle Cell Lymphoma

Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax

Start date: March 1, 2023
Phase:
Study type: Observational

Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart. Objective: To identify and monitor the effects of BTKi on the heart. Eligibility: People aged 18 and older currently receiving or planning to receive BTKi or venetoclax. Design: Participants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit. Participants will undergo multiple tests: A physical exam, including collection of blood and saliva. A test that measures heart activity via stickers placed on the chest. A test that uses sound waves to capture images of the heart. An exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises. Stress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken. Participants may wear a device to monitor their heart at home. Participants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years.

NCT ID: NCT05716789 Completed - Cardiac Arrest Clinical Trials

Cardiopulmonary Resuscitation in Cases of Sudden Cardiac Arrest

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Determination the success rate of CPR on adults in Emergency room and predicting the factors that makes CPR is successful.

NCT ID: NCT05713708 Not yet recruiting - Clinical trials for Sudden Cardiac Death

S-ICD Electrode Registry

Start date: November 1, 2023
Phase:
Study type: Observational

The subcutaneous implantable cardioverter defibrillator (S-ICD) is established in the prevention of sudden cardiac death, but recently a defect of the electrode's Sense-B component was reported in some patients. This lead to inadequate shocks due to noise. The cause and incidence of this defect are unknown. The manufacturer issued a warning regarding this defect and a possible premature depletion of the battery in some device. Independent data on the incidence of these issues is limited. Further data is needed to better understand the risk of these complications.

NCT ID: NCT05713240 Not yet recruiting - Clinical trials for Sudden Cardiac Death

REgiStry in Chinese yoUng pEople With Sudden Cardiac Death

RESCUE-SCD
Start date: March 1, 2023
Phase:
Study type: Observational

The number of sudden cardiac death is up to 540,000 every year in China. Inherited cardiovascular disease is a common cause of sudden cardiac death in young people, and diseases often have the characteristics of family aggregation, so it has a huge psychological and economic burden on family members. Studying the etiology of sudden cardiac death from the molecular level under the model of precision medicine is helpful for screening patients and their relatives so as to further diagnosis, treatment and management, which has important clinical and social significance.

NCT ID: NCT05694572 Recruiting - Heart Failure Clinical Trials

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

PIANO
Start date: October 30, 2023
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.

NCT ID: NCT05665608 Recruiting - Clinical trials for Myocardial Infarction

Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

PROFID EHRA
Start date: November 16, 2023
Phase: N/A
Study type: Interventional

Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative. OBJECTIVE: To demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.

NCT ID: NCT05636332 Completed - Clinical trials for Sudden Cardiac Arrest

The Intrepid Clinical Engineering Study

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.

NCT ID: NCT05587764 Enrolling by invitation - Clinical trials for Sudden Cardiac Arrest

Tempus Pro Monitor Registry

Start date: April 25, 2024
Phase:
Study type: Observational [Patient Registry]

A multicenter, prospective and retrospective, observational, post market study.