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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

Study Description
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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.

Condition or disease Intervention/treatment
Cardiovascular Disease Behavioral: Therapy Programming Report (TPR)

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 Design
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Study Type : Observational
Actual Enrollment : 4384 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Study Start Date : April 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Group/Cohort Intervention/treatment
Analysis cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Lead Integrity Alert (LIA) Performance [ Time Frame: Overall study (20 months on average) ]
    Causes for LIA triggers reported during the study

  2. Reasons for Inappropriate Shocks [ Time Frame: Overall study (20 months on average) ]
    Reasons for inappropriate shocks observed during the study

  3. 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

  4. Barriers to Utilization of Shock Reduction Programming [ Time Frame: 24 months follow-up visit ]
    Characterization of barriers to physician utilization of shock reduction programming

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856349


Locations
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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Marc Silver, M.D. Raleigh Cardiology Associates
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00856349    
Other Study ID Numbers: Shock-Less
First Posted: March 5, 2009    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014
Last Verified: July 2014
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Lead Integrity Alert (LIA)
Therapy Programming Report (TPR)
Additional relevant MeSH terms:
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Cardiovascular Diseases