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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00856349




Registration number
NCT00856349
Ethics application status
Date submitted
26/02/2009
Date registered
4/03/2009
Date last updated
1/07/2014

Titles & IDs
Public title
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Scientific title
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Secondary ID [1] 0 0
Shock-Less
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Shock Reduction Programming Adoption - 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.
Timepoint [1] 0 0
Overall study (20 months on average)
Secondary outcome [1] 0 0
Lead Integrity Alert (LIA) Performance - Causes for LIA triggers reported during the study
Timepoint [1] 0 0
Overall study (20 months on average)
Secondary outcome [2] 0 0
Reasons for Inappropriate Shocks - Reasons for inappropriate shocks observed during the study
Timepoint [2] 0 0
Overall study (20 months on average)
Secondary outcome [3] 0 0
Actions Taken Following a Shock - Characterization of actions taken by the subject immediately following a device shock
Timepoint [3] 0 0
Overall study (20 months on average)
Secondary outcome [4] 0 0
Barriers to Utilization of Shock Reduction Programming - Characterization of barriers to physician utilization of shock reduction programming
Timepoint [4] 0 0
24 months follow-up visit
Secondary outcome [5] 0 0
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization - Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Timepoint [5] 0 0
Overall study (20 months on average)

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 -
EnTrustâ„¢, 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is enrolled in a concurrent study that has not been approved for concurrent
enrollment by the Medtronic Clinical Trial Leader

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Frankston
Recruitment hospital [3] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
North Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
West Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Manitoba
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
China
State/province [41] 0 0
Guangdong
Country [42] 0 0
China
State/province [42] 0 0
Beijing
Country [43] 0 0
Hong Kong
State/province [43] 0 0
Kowloon
Country [44] 0 0
India
State/province [44] 0 0
Delhi
Country [45] 0 0
India
State/province [45] 0 0
New Dehli
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Mexico
State/province [47] 0 0
Mexico City
Country [48] 0 0
New Zealand
State/province [48] 0 0
Hamilton
Country [49] 0 0
Singapore
State/province [49] 0 0
Singapore
Country [50] 0 0
Taiwan
State/province [50] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00856349
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Silver, M.D.
Address 0 0
Raleigh Cardiology Associates
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications