Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00856349 |
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Recruitment Status :
Completed
First Posted : March 5, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
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Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
- Study Details
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| Study Type | Observational |
|---|---|
| Study Design | Observational Model: Cohort; Time Perspective: Prospective |
| Condition |
Cardiovascular Disease |
| Intervention |
Behavioral: Therapy Programming Report (TPR) |
| Enrollment | 4384 |
Participant Flow
| Recruitment Details | 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 | 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%). |
| Arm/Group Title | Analysis Cohort |
|---|---|
 Arm/Group Description |
Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints. |
| Period Title: Overall Study | |
| Started | 4132 |
| 12 Month Follow-up | 3228 |
| 18 Month Follow-up | 2467 |
| 24 Month Follow-up | 1698 |
| Completed | 3111 |
| Not Completed | 1021 |
| Reason Not Completed | |
| 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
| Arm/Group Title | Analysis Cohort | |
|---|---|---|
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Arm/Group Description |
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. |
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| Overall Number of Baseline Participants | 4132 | |
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Baseline Analysis Population Description |
Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 4132 participants | |
| 66 (13) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 4132 participants | |
| Female |
971 23.5%
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| Male |
3161 76.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 4132 participants | |
| American Indian or Alaska Native |
14 0.3%
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| Asian |
295 7.1%
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| Native Hawaiian or Other Pacific Islander |
9 0.2%
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| Black or African American |
360 8.7%
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| White |
3151 76.3%
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| More than one race |
5 0.1%
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| Unknown or Not Reported |
298 7.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 4132 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
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
Results Point of Contact
| Name/Title: | Daniel Lexcen, Clinical Research Specialist |
| Organization: | Medtronic Cardiac Rhythm Disease Management |
| Phone: | 763-526-9702 |
| EMail: | daniel.lexcen@medtronic.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
| ClinicalTrials.gov Identifier: | NCT00856349 |
| Other Study ID Numbers: |
Shock-Less |
| First Submitted: | February 26, 2009 |
| First Posted: | March 5, 2009 |
| Results First Submitted: | May 22, 2014 |
| Results First Posted: | July 3, 2014 |
| Last Update Posted: | July 3, 2014 |