Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators

With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.

Inclusion criteria

• Ischemic or nonischemic cardiomyopathy
• Primary prevention or secondary prevention of Sudden cardiac death (SCD)
• Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber)
• The patient is ≥ 18 years of age
• The patient is able to understand the patient information and is capable to provide informed consent.
• The patient has provided written informed consent prior to any investigational related procedure

Exclusion criteria

• Previously implanted ICD/CRT-D
• Hypertrophic (with or without obstructive) cardiomyopathy
• Ion channel disorders (Long/Short-QT, Brugada syndrome etc…)
• New York Heart Association (NYHA) Class IV
• Recent cardiac decompensation (within previous 3 months)
• The patient is unable to comply with the follow up schedule.
• The patient is participating in another investigational device or drug investigation.
• The patient is pregnant or is planning to become pregnant during the duration of the investigation