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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Therapy Programming Report (TPR)


Participation Criteria
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Eligibility Criteria
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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
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 |
| --- | --- |
| Analysis cohort<br>Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. | Behavioral: Therapy Programming Report (TPR)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Overall study (20 months on average) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy-Defibrillator (CRT-D), Lead Integrity Alert (LIA), Therapy Programming Report (TPR)