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DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study

2014-07-23 21:48:45 | BioPortfolio

Summary

The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs (DDED), to reduce clinically significant adverse events as compared to single chamber ICD in a non selected population with conventional indication of ICD implantation.

Description

Single chamber (SC) implantable cardioverter defibrillators (ICDs) have several limitations that might be relevant during follow up, like atrial pacing requirements, inadequate therapies, sustained atrial tachyarrhythmias and difficulties to achieve an accurate diagnosis of the arrhythmia. Dual chamber (DC) ICDs offer an attractive rationale solution, although controversy remains if the costs and complexity of the implants offer a real clinical advantage.

The DATAS is a, prospective, multicentre, randomized, open labelled study, with three arms (two of them cross-over and the third parallels the other two)

The primary objective of this trial is to determine whether use of DDED ICD results in a significant decrease in the number of primary end points.

The primary end point is a composite comprising four so-denominated "Clinically Significant Adverse Events":

1. all-cause mortality

2. invasive intervention, hospitalization (>24 h) or prolongation of hospitalization due to cardiovascular cause

3. inappropriate shocks (two or more episodes with inappropriate shocks)

4. sustained symptomatic atrial tachyarrhythmias that (a) require urgent termination or (b) last more than 48 h leading to therapeutic intervention.

Secondary objectives are:

1. Number of each of the components of the CSAE.

2. Arrhythmia related: atrial tachyarrhythmia, frequency and burden, ventricular tachyarrhythmia frequency and burden number of appropriate shocks, number of inappropriate shocks, need for reprogramming, need for medication/RFA for arrhythmia control, pacemaker syndrome and development of dual chamber pacing indication.

3. Cardiovascular related: NYHA functional class, exercise capacity, left ventricular ejection fraction (LVEF), reduction of medication (diuretics.).

4. Quality of life: evaluated by the SF-36, Minnesota living test, with heart failure and Symptom Checklist instruments.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Conditions

Implantable Cardioverter-Defibrillators

Intervention

Implantable Cardioverter Defibrillator

Status

Active, not recruiting

Source

Medtronic Bakken Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:45-0400

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The Gulf Implantable Cardioverter-Defibrillator Registry

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PubMed Articles [279 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review.

Subcutaneous implantable cardioverter defibrillators (S-ICDs) are considered an alternative to conventional transvenous ICDs (TV-ICDs) in patients not requiring pacing.

Manufacturer change and risk of system-related complications after implantable cardioverter defibrillator replacement: physicians' survey and data from the Detect Long-term Complications After Implantable Cardioverter Defibrillator Replacement Registry.

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Subcutaneous cardioverter defibrillator has longer time to therapy but is less cardiotoxic than transvenous cardioverter defibrillator. Study carried out in a preclinical porcine model.

Totally subcutaneous implantable cardioverter defibrillator (S-ICD) delivers higher shock energy and can have longer time to therapy compared to transvenous implantable cardioverter defibrillator (T-I...

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Medical and Biotech [MESH] Definitions

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.

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.

Surgically placed electric conductors through which ELECTRIC STIMULATION of nerve tissue is delivered.

Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)

Implanted fluid propulsion systems with self-contained power source for providing long-term controlled-rate delivery of drugs such as chemotherapeutic agents or analgesics. Delivery rate may be externally controlled or osmotically or peristatically controlled with the aid of transcutaneous monitoring.

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