Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Phase 3

Completed

• Conditions: Sudden Cardiac Death

• Registration Number: NCT00586378
• Lead Sponsor: ELA Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Shock effectiveness for VT/VF	6 months
The percentage of patients free from complications	6 months

Trial Locations

Locations (1)

Banner Baywood; 🇺🇸 Mesa, Arizona, United States