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Completed

NCT Number: NCT00856349

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires, Argentina

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapy Programming Report (TPR)

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2009
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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