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

• 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: Medtronic Cardiac Rhythm and Heart Failure
• 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

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

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