Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

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

Completed

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Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Banner Baywood

Mesa, Arizona, 85206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ovatio DR and Ovatio VR

Device

implantable cardioverter defibrillator

Other names: Ovatio DR 6550 Dual-Chamber ICD, Ovatio VR 6250 Single-Chamber ICD

Primary outcomes

The percentage of patients free from complications

Time frame: 6 months
Shock effectiveness for VT/VF

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

ELA Medical, Inc.

Industry

Registry information

Acronym: Post-Ovatio

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jan 4, 2008
Registry last updated: Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed