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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
Results First Received: May 22, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Cardiovascular Disease
Intervention: Behavioral: Therapy Programming Report (TPR)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in the Shock-Less study between April 2009 and January 2012 from 118 centers worldwide in North America, Central/South America, Australia/New Zealand and Asia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 252 (6%) out of the 4384 enrolled subjects were excluded from the analysis cohort due to the following reasons: baseline device interrogation not available (217/252; 86%), inclusion/exclusion criteria not met (16/252, 6%), indication for ICD implant not specified (11/252; 4%), and VF therapy/detection not turned ON (8/252; 3%).

Reporting Groups
  Description
Analysis Cohort Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.

Participant Flow:   Overall Study
    Analysis Cohort  
STARTED     4132  
12 Month Follow-up     3228  
18 Month Follow-up     2467  
24 Month Follow-up     1698  
COMPLETED     3111  
NOT COMPLETED     1021  
Death                 418  
Withdrawal by Subject                 116  
Lost to Follow-up                 91  
Protocol Violation                 38  
Physician Decision                 13  
Subject relocation                 104  
Device explant                 33  
Site closure                 78  
Subject changed Dr, insurance issue, etc                 130  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

Reporting Groups
  Description
Analysis Cohort

Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

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.


Baseline Measures
    Analysis Cohort  
Number of Participants  
[units: participants]
  4132  
Age  
[units: years]
Mean ± Standard Deviation
  66  ± 13  
Gender  
[units: participants]
 
Female     971  
Male     3161  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     14  
Asian     295  
Native Hawaiian or Other Pacific Islander     9  
Black or African American     360  
White     3151  
More than one race     5  
Unknown or Not Reported     298  
Region of Enrollment  
[units: participants]
 
United States     3307  
Taiwan     27  
Hong Kong     15  
Mexico     8  
Canada     434  
Argentina     19  
Singapore     39  
Australia     69  
New Zealand     26  
China     28  
Korea, Republic of     24  
India     118  
Thailand     18  



  Outcome Measures
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1.  Primary:   Change in Shock Reduction Programming Adoption   [ Time Frame: Overall study (20 months on average) ]

2.  Secondary:   Lead Integrity Alert (LIA) Performance   [ Time Frame: Overall study (20 months on average) ]

3.  Secondary:   Reasons for Inappropriate Shocks   [ Time Frame: Overall study (20 months on average) ]

4.  Secondary:   Actions Taken Following a Shock   [ Time Frame: Overall study (20 months on average) ]

5.  Secondary:   Barriers to Utilization of Shock Reduction Programming   [ Time Frame: 24 months follow-up visit ]

6.  Secondary:   Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization   [ Time Frame: Overall study (20 months on average) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Daniel Lexcen, Clinical Research Specialist
Organization: Medtronic Cardiac Rhythm Disease Management
phone: 763-526-9702
e-mail: daniel.lexcen@medtronic.com


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