Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Completed · Phase 3

Conditions studied: Sudden Cardiac Death

In brief

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

Key facts

Study ID

NCT00586378

Run by

ELA Medical, Inc.

People needed

85

Starts

2006-04-01

Expected to finish

2009-12-01

Last updated by the study team

2012-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Banner Baywood — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.