Feature Assessment Study for Indications Based Programming

Study Overview
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Brief Summary
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The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.

Detailed Description
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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

Official Title
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Feature Assessment Study for Indications Based Programming

Conditions
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Ventricular Tachycardia, Ventricular Flutter, Ventricular Fibrillation, Heart Failure

Intervention / Treatment
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* Device: Cognis 100-D, Teligen DR and VR 100 HE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD and CRT-D<br>Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator | Device: Cognis 100-D, Teligen DR and VR 100 HE<br>* Teligen is an implantable defibrillator for detection and termination of life threatening arrhythmias. Cognis includes in addition to these capabilities cardiac resynchronization therapy for patients having heart failure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Degree of acceptance of IBP - Proportion parameters changed per patient - Differences between recommended and final programmed parameters - Total number of parameter changes from IBP recommendations - Frequency of changes made to a single parameter |  | 6 Months |