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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00856349
First received: February 26, 2009
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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 Intervention
Cardiovascular Disease
Behavioral: Therapy Programming Report (TPR)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Change in Shock Reduction Programming Adoption [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]

    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:
  • Lead Integrity Alert (LIA) Performance [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]
    Causes for LIA triggers reported during the study

  • Reasons for Inappropriate Shocks [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]
    Reasons for inappropriate shocks observed during the study

  • Actions Taken Following a Shock [ Time Frame: Overall study (20 months on average) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Characterization of shock reduction programming utilization by subject characteristics and geographical regions


Enrollment: 4384
Study Start Date: April 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856349

  Show 104 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Marc Silver, M.D. Raleigh Cardiology Associates
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00856349     History of Changes
Other Study ID Numbers: Shock-Less
Study First Received: February 26, 2009
Results First Received: May 22, 2014
Last Updated: July 1, 2014
Health Authority: Argentina: Human Research Bioethics Committee
Australia: Human Research Ethics Committee
Brazil: Ethics Committee
China: Medical Ethics Committee
Colombia: Institutional Review Board
Hong Kong: Research Ethics Committee
India: Ethics Committee
Israel: Ethics Committee
Mexico: Ethics Committee
New Zealand: Regional Ethics Committee
Singapore: Domain Specific Review Boards
South Korea: Institutional Review Board
Taiwan: Institutional Review Board
Thailand: Research Ethics Committee
Venezuela: Ethics Committee

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Lead Integrity Alert (LIA)
Therapy Programming Report (TPR)

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014