Clinical Trials/NCT00586378

NCT00586378

Completed

Phase 3

Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

ELA Medical, Inc.1 site in 1 country85 target enrollmentApril 2006

ConditionsSudden Cardiac Death

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Sudden Cardiac Death
Sponsor: ELA Medical, Inc.
Enrollment: 85
Locations: 1
Primary Endpoint: Shock effectiveness for VT/VF
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

December 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ELA Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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
•Participating in another clinical study

Outcomes

Primary Outcomes

Shock effectiveness for VT/VF

Time Frame: 6 months

The percentage of patients free from complications

Time Frame: 6 months

Study Sites (1)

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