Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs

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Detailed Description

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Conditions

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Sudden Cardiac Death

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ovatio DR and Ovatio VR

implantable cardioverter defibrillator

Intervention Type DEVICE

Other Intervention Names

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Ovatio DR 6550 Dual-Chamber ICD Ovatio VR 6250 Single-Chamber ICD

Eligibility Criteria

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Inclusion Criteria

* Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the "ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" (Zipes et al., JACC Vol. 48, No. 5, Sept. 2006:1064-1108).

Exclusion Criteria

* Ventricular tachyarrhythmia that may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes
* Incessant tachyarrhythmia
* Implanted pacemaker
* Primary disorder of bradyarrhythmia or atrial tachyarrhythmia
* Of minor age
* Pregnant
* Participating in another clinical study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No