Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

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

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