Medtronic Shock-Less Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00856349
First received: February 26, 2009
Last updated: November 1, 2012
Last verified: November 2012

February 26, 2009
November 1, 2012
April 2009
March 2013   (final data collection date for primary outcome measure)
Proportion of subjects with changes in shock reduction programming from baseline to the end of follow-up. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 performance data. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Reasons for inappropriate shocks. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Barriers to utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Actions taken following a shock. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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Medtronic Shock-Less Study
Medtronic Shock-Less Study

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: Case-Only
Time Perspective: Prospective
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4380
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
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   China,   Hong Kong,   India,   Korea, Republic of,   Mexico,   New Zealand,   Singapore,   Taiwan
 
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
November 2012

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