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Cameron Health Subcutaneous Implantable Defibrillator (S-ICD) System Patient Registry (CHIP)

2014-08-27 03:15:17 | BioPortfolio

Summary

This objective of this study is to confirm the long-term safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.

Description

This registry will collect long-term data to further characterize the continued safety and performance of the S-ICD System. Patients implanted with a CE Marked S-ICD System, not participating in the Cameron Health's IDE clinical study will be enrolled in this registry. This study is designed to be a post-implant registry, and patients are meant to be seen in accordance with the institution's standard of care.

The primary objective of this registry is to track patient demographic and longitudinal data on the use and function of the S-ICD System. A secondary objective is to evaluate long-term performance through an evaluation of spontaneous episodes.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Tachycardia, Ventricular

Intervention

S-ICD System

Location

Christchurch Hospital
Christchurch
New Zealand

Status

Not yet recruiting

Source

Cameron Health, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:17-0400

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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.

An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation).

A malignant form of polymorphic ventricular tachycardia that is characterized by HEART RATE between 200 and 250 beats per minute, and QRS complexes with changing amplitude and twisting of the points. The term also describes the syndrome of tachycardia with prolonged ventricular repolarization, long QT intervals exceeding 500 milliseconds or BRADYCARDIA. Torsades de pointes may be self-limited or may progress to VENTRICULAR FIBRILLATION.

Cardiac electrical stimulators that apply brief high-voltage electroshocks to the HEART. These stimulators are used to restore normal rhythm and contractile function in hearts of patients who are experiencing VENTRICULAR FIBRILLATION or ventricular tachycardia (TACHYCARDIA, VENTRICULAR) that is not accompanied by a palpable PULSE. Some defibrillators may also be used to correct certain noncritical dysrhythmias (called synchronized defibrillation or CARDIOVERSION), using relatively low-level discharges synchronized to the patient's ECG waveform. (UMDNS, 2003)

A potentially lethal cardiac arrhythmia characterized by an extremely rapid, hemodynamically unstable ventricular tachycardia (150-300 beats/min) with a large oscillating sine-wave appearance. If untreated, ventricular flutter typically progresses to VENTRICULAR FIBRILLATION.

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