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D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

2014-07-23 21:43:39 | BioPortfolio

Summary

This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

Description

The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Heart Diseases

Intervention

Implantable Cardioverter Defibrillator

Location

Tampa
Florida
United States

Status

Completed

Source

Medtronic Cardiac Rhythm Disease Management

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:43:39-0400

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Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

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The Gulf Implantable Cardioverter-Defibrillator Registry

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Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)

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SecuraTM ICD Clinical Evaluation Study

The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)

PubMed Articles [12161 Associated PubMed Articles listed on BioPortfolio]

Persistent sex disparities in implantable cardioverter-defibrillator therapy.

Clinical guidelines recommend cardioverter defibrillator implantation for patients with heart failure and reduced ejection fraction. Despite this, women and minorities have been less likely to receive...

Effectiveness of Implantation of Cardioverter-Defibrillators Therapy in Patients with Non-Ischemic Heart Failure: an Updated Systematic Review and Meta-Analysis.

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Exploring the patients' experiences of living with a subcutaneous implantable cardioverter defibrillator.

The implantable cardioverter defibrillator provides effective treatment for the prevention of sudden cardiac arrest but significant risks associated with transvenous implantation persist. The subcutan...

Comparison of pharmacological treatment alone vs. treatment combined with implantable cardioverter defibrillator therapy in patients older than 75 years.

Implantable cardioverter defibrillator (ICD) reduces mortality in selected patients. However, its role in patients older than 75 years is not well established.

Predictors of ECG Screening Failure for the Subcutaneous Implantable Cardioverter Defibrillator in Children. A Prospective Multi-Center Study.

Subcutaneous Implantable Cardioverter Defibrillator (SICD) shows promise for select patients at risk for sudden death. However, patients need to pass an ECG screening (ECG-S) test before they can rece...

Medical and Biotech [MESH] Definitions

Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes.

Small pumps, often implantable, designed for temporarily assisting the heart, usually the left ventricle, to pump blood; they consist of a pumping chamber and a power source, which may be partially or totally external to the body and activated by electromagnetic motors; the devices are used after myocardial infarction or to wean the repaired heart from the heart-lung machine after open-heart surgery.

Types of artificial pacemakers with implantable leads to be placed at multiple intracardial sites. They are used to treat various cardiac conduction disturbances which interfere with the timing of contraction of the ventricles. They may or may not include defibrillating electrodes (IMPLANTABLE DEFIBRILLATORS) as well.

Occlusion of the outflow tract in either the LEFT VENTRICLE or the RIGHT VENTRICLE of the heart. This may result from CONGENITAL HEART DEFECTS, predisposing heart diseases, complications of surgery, or HEART NEOPLASMS.

Pathological conditions involving the HEART including its structural and functional abnormalities.

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