Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming|
- Change in Shock Reduction Programming Adoption [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]
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.
- Lead Integrity Alert (LIA) Performance [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]Causes for LIA triggers reported during the study
- Reasons for Inappropriate Shocks [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]Reasons for inappropriate shocks observed during the study
- Actions Taken Following a Shock [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]Characterization of actions taken by the subject immediately following a device shock
- Barriers to Utilization of Shock Reduction Programming [ Time Frame: 24 months follow-up visit ] [ Designated as safety issue: No ]Characterization of barriers to physician utilization of shock reduction programming
- Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]Characterization of shock reduction programming utilization by subject characteristics and geographical regions
|Study Start Date:||April 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Behavioral: Therapy Programming Report (TPR)
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856349
Show 104 Study Locations
|Principal Investigator:||Marc Silver, M.D.||Raleigh Cardiology Associates|