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Implantable Defibrillator User clinical trials

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NCT ID: NCT02491853 Completed - Clinical trials for Implantable Defibrillator User

The Gulf Implantable Cardioverter-Defibrillator Registry

GulfICD
Start date: January 2014
Phase: N/A
Study type: Observational [Patient Registry]

This is a prospective observational multi-center multi-national study of the characteristics and outcomes of patients receiving implantable cardioverter-defibrillators (ICD) in the Arab Gulf region. A total of 1,500 patients will be enrolled. Data on baseline clinical characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as mortality and ICD discharges over 1 year of follow-up will be collected.

NCT ID: NCT02232204 Completed - Insomnia Clinical Trials

Sleep and Ventricular Arrhythmias Study

SAVE
Start date: October 2009
Phase: Phase 2
Study type: Interventional

This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment intervention period lasted 4 weeks with a telephone booster session administered at 3 month follow-up. The objective of the study is to examine the impact of a brief therapy combining established behavioral approaches to treating insomnia with novel components to target negative cognitions and anxieties associated with cardiac disease and ICD implantation. Primary patient outcomes include sleep, psychological functioning, daytime functioning, cardiac functioning, cognitive performance, and ICD adjustment.

NCT ID: NCT02064192 Completed - Clinical trials for Coronary Artery Disease

Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe

EU-CERT-ICD
Start date: May 2014
Phase:
Study type: Observational

The "EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD)" is a modular research project to study the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and meta-analyses of existing evidence on the subject.

NCT ID: NCT01944514 Completed - Clinical trials for Myocardial Infarction

Implantable Cardioverter Defibrillators - Improving Risk Stratification

ICD-IRS
Start date: January 2010
Phase: N/A
Study type: Observational

Worldwide three million people a year die from sudden cardiac death (SCD). In most cases there is no warning and the heart is stopped by a sudden arrhythmia. We know that some people are at high risk of sudden cardiac death and can prevent their deaths with an implantable cardioverter defibrillator (ICD) that is implanted in a minor operation. However, most people who die from sudden cardiac death are not found to be at high risk by our current risk markers and 40% of the people who have ICDs do not have therapy within the first 4 years after implant. We need new and better ways of identifying people who are at high risk of sudden cardiac death so that we can prevent their deaths with ICDs. Our understanding of the electrical signals in the heart has increased considerably in recent years; in no small part this is due to our Principal Investigator Professor Andre Ng's basic science work. This study aims to take the understanding of action potential duration (APD) restitution gained through our work and other studies in humans and in computer simulations and translate it into a fresh way of assessing risk of sudden cardiac death. This study will carefully examine electrical activity, using APD restitution, in the hearts of patients who are having ICDs fitted because of their high risk of sudden cardiac death and combine this with a detailed heart scan, assessment of autonomic nervous system and gene expression data. We will then follow these patients up to see who benefits from their ICD. This wide ranging information will give us as complete a picture as possible of the factors that cause sudden cardiac death. We hope to use this to identify better predictors of sudden cardiac death. The study hypotheses are as follows: Primary 1. Regional Restitution Instability Index (R2I2) will be significantly higher in patients reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not. 2. An R2I2 cut-off of 1.03 will partition patients into high and low risk groups. Secondary 3. Peri-infarct zone mass in grams will be significantly higher in patients reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.