Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Consent Form (PCF) and authorization for access to and use of health information, if applicable
Subject has been implanted with a Medtronic market released ICD or CRT-D device (US/Canada - Concerto®/Virtuoso® or newer model; AsiaPacific, Israel, Latin America - EnTrust™, InSync Sentry®, or Concerto®/Virtuoso® or newer model) within the past 30 days
Subject has commercially released RA (if applicable), RV, and LV (if applicable) leads

Exclusion Criteria

Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader

Arm && Interventions

Group	Intervention	Description
Analysis cohort	Therapy Programming Report (TPR)	Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

Primary Outcome Measures

Name	Time	Method
Change in Shock Reduction Programming Adoption	Overall study (20 months on average)	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.

Secondary Outcome Measures

Name	Time	Method
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization	Overall study (20 months on average)	Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Reasons for Inappropriate Shocks	Overall study (20 months on average)	Reasons for inappropriate shocks observed during the study
Lead Integrity Alert (LIA) Performance	Overall study (20 months on average)	Causes for LIA triggers reported during the study
Actions Taken Following a Shock	Overall study (20 months on average)	Characterization of actions taken by the subject immediately following a device shock
Barriers to Utilization of Shock Reduction Programming	24 months follow-up visit	Characterization of barriers to physician utilization of shock reduction programming