Feature Assessment Study for Indications Based Programming

"This study will focus on documenting the final parameter changes that are made in comparison to the IBP recommendations for a specific cardiovascular and arrhythmia history. It will therefore compare the device settings that were finally programmed during the last available follow up procedure to the last available parameter recommendations of IBP. IBP was designed to facilitate programming by providing customized parameter settings based on a patient's clinical needs and primary indication.

In order to further enhance the IBP feature for future device generations, additional data may be collected and evaluated on:

• Physician perception and satisfaction with the New User Interface (NUI) of the programming application;
• Motivation for adapting IBP recommendations for the final programming of the device;
• Device data that can be retrieved from patient data disks that may include but is not limited to, arrhythmia episode detail, pacing counter data; total and individual therapy data"

Inclusion criteria

• indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines

• Implanted or intended to be implanted with any CE-marked device approved for implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family during first implant (no replacements)
• Geographically stable patients who are available for follow-up at a study centre
• Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion criteria

Inability or refusal to sign the Patient Informed Consent

• Pregnant or planning to become pregnant
• Replacement device
• Enrolment in another clinical trial, study or evaluation
• Estimated life expectancy of less than six months per discretion of physician