Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
|ClinicalTrials.gov Identifier: NCT00856349|
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
|Condition or disease||Intervention/treatment|
|Cardiovascular Disease||Behavioral: Therapy Programming Report (TPR)|
|Study Type :||Observational|
|Actual Enrollment :||4384 participants|
|Official Title:||Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming|
|Study Start Date :||April 2009|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
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.
- Change in Shock Reduction Programming Adoption [ Time Frame: 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.
- Lead Integrity Alert (LIA) Performance [ Time Frame: Overall study (20 months on average) ]Causes for LIA triggers reported during the study
- Reasons for Inappropriate Shocks [ Time Frame: Overall study (20 months on average) ]Reasons for inappropriate shocks observed during the study
- Actions Taken Following a Shock [ Time Frame: 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 [ Time Frame: 24 months follow-up visit ]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) ]Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856349
Show 104 Study Locations
|Principal Investigator:||Marc Silver, M.D.||Raleigh Cardiology Associates|