The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for defibrillators.
Shocks delivered to patients by defibrillators, while life-saving, can create anxiety, pain and decrease quality of life. Previous studies have shown that device programming and features can safely reduce the number of shocks patients receive. This study will explore the extent to which physicians use these programming and features. It will determine whether repeat and frequent awareness to how they program their own subjects and the programming trends of all enrolled subjects will change their programming patterns. This will be accomplished by understanding physicians' device programming behaviors and providing reports as a tool to help physicians manage their subjects and provide shock reduction programming recommended by previous publications.
Study Type
OBSERVATIONAL
Enrollment
4,384
Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study.
Change in Shock Reduction Programming Adoption
Change in percentage of subjects programmed to evidence-based target from baseline (pre-TPR distribution) to last follow-up (post-TPR distribution). Shock-reduction programming parameters: LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock. SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias. VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients. VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients. Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs. PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.
Time frame: Overall study (20 months on average)
Lead Integrity Alert (LIA) Performance
Causes for LIA triggers reported during the study
Time frame: Overall study (20 months on average)
Reasons for Inappropriate Shocks
Reasons for inappropriate shocks observed during the study
Time frame: Overall study (20 months on average)
Actions Taken Following a Shock
Characterization of actions taken by the subject immediately following a device shock
Time frame: Overall study (20 months on average)
Barriers to Utilization of Shock Reduction Programming
Characterization of barriers to physician utilization of shock reduction programming
Time frame: 24 months follow-up visit
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Unnamed facility
Anniston, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Fremont, California, United States
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Fresno, California, United States
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Modesto, California, United States
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Northridge, California, United States
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Orange, California, United States
...and 94 more locations
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Time frame: Overall study (20 months on average)