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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
BEHAVIORAL - Therapy Programming Report (TPR)

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

Outcomes
Primary outcome [1] 0 0
Change in Shock Reduction Programming Adoption
Timepoint [1] 0 0
Overall study (20 months on average)
Secondary outcome [1] 0 0
Lead Integrity Alert (LIA) Performance
Timepoint [1] 0 0
Overall study (20 months on average)
Secondary outcome [2] 0 0
Reasons for Inappropriate Shocks
Timepoint [2] 0 0
Overall study (20 months on average)
Secondary outcome [3] 0 0
Actions Taken Following a Shock
Timepoint [3] 0 0
Overall study (20 months on average)
Secondary outcome [4] 0 0
Barriers to 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
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 - 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
Minimum age
No limit
Maximum age
No limit
Sex
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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
4384
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
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Florida
Country [7] 0 0
United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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United States of America
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New Mexico
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New York
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North Carolina
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North Dakota
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United States of America
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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United States of America
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Tennessee
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Texas
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United States of America
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Virginia
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Canada
State/province [36] 0 0
Alberta
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Canada
State/province [37] 0 0
British Columbia
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Canada
State/province [38] 0 0
Manitoba
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Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
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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
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India
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New Dehli
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Korea, Republic of
State/province [46] 0 0
Seoul
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Mexico
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Mexico City
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New Zealand
State/province [48] 0 0
Hamilton
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Singapore
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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/study/NCT00856349
Trial related presentations / publications
Joung B, Lexcen DR, Ching CK, Silver MT, Piccini JP, Sterns LD, Rabinovich R, Pickett RA, Liu S, Brown ML, Cheng A. Additional antitachycardia pacing programming strategies further reduce unnecessary implantable cardioverter-defibrillator shocks. Heart Rhythm. 2020 Jan;17(1):98-105. doi: 10.1016/j.hrthm.2019.07.027. Epub 2019 Jul 29.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00856349