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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00856349
Registration number
NCT00856349
Ethics application status
Date submitted
26/02/2009
Date registered
5/03/2009
Date last updated
3/07/2014
Titles & IDs
Public title
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
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Scientific title
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
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Secondary ID [1]
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Shock-Less
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Behaviour - Therapy Programming Report (TPR)
Analysis cohort - Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Behaviour: 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.
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Shock Reduction Programming Adoption
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Assessment method [1]
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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.
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Timepoint [1]
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Overall study (20 months on average)
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Secondary outcome [1]
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Lead Integrity Alert (LIA) Performance
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Assessment method [1]
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Causes for LIA triggers reported during the study
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Timepoint [1]
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Overall study (20 months on average)
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Secondary outcome [2]
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Reasons for Inappropriate Shocks
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Assessment method [2]
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Reasons for inappropriate shocks observed during the study
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Timepoint [2]
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Overall study (20 months on average)
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Secondary outcome [3]
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Actions Taken Following a Shock
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Assessment method [3]
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Characterization of actions taken by the subject immediately following a device shock
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Timepoint [3]
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Overall study (20 months on average)
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Secondary outcome [4]
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Barriers to Utilization of Shock Reduction Programming
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Assessment method [4]
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Characterization of barriers to physician utilization of shock reduction programming
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Timepoint [4]
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24 months follow-up visit
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Secondary outcome [5]
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Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
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Assessment method [5]
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Characterization of shock reduction programming utilization by subject characteristics and geographical regions
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Timepoint [5]
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Overall study (20 months on average)
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject is enrolled in a concurrent study that has not been approved for concurrent
enrollment by the Medtronic Clinical Trial Leader
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2013
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Sample size
Target
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Accrual to date
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Final
4384
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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- Adelaide
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- Frankston
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- Perth
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- Adelaide
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- Frankston
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- Perth
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Cardiac Rhythm and Heart Failure
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00856349
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marc Silver, M.D.
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Address
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Raleigh Cardiology Associates
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00856349
Download to PDF