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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00856349
First received: February 26, 2009
Last updated: July 1, 2014
Last verified: July 2014

February 26, 2009
July 1, 2014
April 2009
March 2013   (final data collection date for primary outcome measure)
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.

Determine whether periodic reports provided to study centers can increase the utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00856349 on ClinicalTrials.gov Archive Site
  • 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
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Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

Subjects implanted with a Medtronic market released single, dual, or triple chamber defibrillator (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 are eligible for participation in the study.

Cardiovascular Disease
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.
Analysis cohort
Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Intervention: Behavioral: Therapy Programming Report (TPR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4384
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Taiwan,   Argentina,   Australia,   Canada,   China,   Hong Kong,   India,   Korea, Republic of,   Mexico,   New Zealand,   Singapore
 
NCT00856349
Shock-Less
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Principal Investigator: Marc Silver, M.D. Raleigh Cardiology Associates
Medtronic Cardiac Rhythm Disease Management
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP