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

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ClinicalTrials.gov Identifier: NCT00856349
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date February 26, 2009
First Posted Date March 5, 2009
Results First Submitted Date May 22, 2014
Results First Posted Date July 3, 2014
Last Update Posted Date July 3, 2014
Study Start Date April 2009
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2014)
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.
Original Primary Outcome Measures
 (submitted: March 4, 2009)
Determine whether periodic reports provided to study centers can increase the utilization of shock reduction programming. [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT00856349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 1, 2014)
  • 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Official Title Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Cardiovascular Disease
Intervention 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.
Study Groups/Cohorts Analysis cohort
Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Intervention: Behavioral: Therapy Programming Report (TPR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2014)
4384
Original Estimated Enrollment
 (submitted: March 4, 2009)
2500
Actual Study Completion Date March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Australia,   Canada,   China,   Hong Kong,   India,   Korea, Republic of,   Mexico,   New Zealand,   Singapore,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00856349
Other Study ID Numbers Shock-Less
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Not Provided
Investigators
Principal Investigator: Marc Silver, M.D. Raleigh Cardiology Associates
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date July 2014