Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study (Post-Ovatio)

ELA Medical

Status and phase: Completed; Phase 3

Conditions: Sudden Cardiac Death

Treatments: Device: Ovatio DR and Ovatio VR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00586378

ITAC05

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)