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Implantable Defibrillator User clinical trials

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NCT ID: NCT04981496 Active, not recruiting - Cardiomyopathies Clinical Trials

Novel ICD Arrhythmia Detection Algorithm

Start date: July 6, 2021
Phase:
Study type: Observational

Implantable cardioverter defibrillators (ICD) are used to treat life-threatening heart rhythm disturbances (arrhythmias). They have been proven to reduce the risk of sudden cardiac death; however, there are limitations with current ICDs. Firstly, they may deliver inappropriate therapies (therapies delivered in the absence of life-threatening arrhythmias). Secondly, slower life-threatening arrhythmias may be left untreated because current programming recommendations, designed to minimise inappropriate therapies, rely predominantly on heart rates. Therefore, there is considerable potential to make ICDs safer with more sophisticated ICD algorithms. In this research study the investigators will collect data from participants with newly implanted or existing ICDs whilst they are in induced or spontaneously occurring abnormal rhythms. The data will come from sensors placed on the skin that can measure blood flow or electrical properties of the body. In addition, in 20 participants, the investigators will also collect further data from a small loop recorder implanted under the skin. The investigators will use this data to help develop and validate new methods of reliably identifying life-threatening arrhythmias so that future ICDs deliver therapies when only needed. The research is funded by the British Heart Foundation, and will take place at Hammersmith Hospital over 3 years. The investigators aim to recruit 100 patients in total.

NCT ID: NCT04765943 Active, not recruiting - Clinical trials for Myocardial Infarction

Prognosis Impact of NSVTs After an AMI (TeVeO Study).

TeVeO
Start date: August 15, 2020
Phase:
Study type: Observational

Nowadays, Sudden Cardiac Death (SCD) due to malignant arrhythmias is an important cause of death among acute myocardial infarction (AMI) survivors. Preventive strategies with implantable cardioverter-defibrillators (ICD) are the best clinical option for patients, but associated sociosanitary impact in the National Health Systems and the fact that current implant strategy not always results in benefits for the patient requires to develop further selection criteria. The TeVeO project aims to study the events that take place early following an AMI to predict the short- and long-term risk of experiencing a potentially lethal ventricular tachycardia (VT). The project will carry out an observational and multicentric study involving 5 different hospitals to: a) qualitative and quantitative characterize non-sustained VTs (NSVT) that take place during the first 6 months after an AMI and b) characterize the evolution of the substrate (scar and surrounding tissue) in patients meeting criteria for ICD implant. Patients included in the study will be implanted with an implantable loop recorder (ILR) in order to register NSVT and cMRI images will be acquired prior to hospital discharge and at 6 months after AMI to study the substrate. Further patients' management will follow the protocols within each entity. Project results will allow us to stratify patients according to identified risks for developing malignant VT, which will improve patient selection for ICD implantation and will contribute to tailor patients' treatment and prevention, improving the cost-effectiveness of these devices and minimizing their associated problems and sociosanitary burden.

NCT ID: NCT03884608 Active, not recruiting - Cardiomyopathies Clinical Trials

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

BIO-LIBRA
Start date: May 9, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.

NCT ID: NCT02864771 Active, not recruiting - Heart Disease Clinical Trials

Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias

SMASH 1
Start date: August 2016
Phase:
Study type: Observational

The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.