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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.
Shocks delivered to patients by defibrillators, while life-saving, can create anxiety, pain and decrease quality of life. Previous studies have shown that device programming and features can safely reduce the number of shocks patients receive. This study will explore the extent to which physicians use these programming and features. It will determine whether repeat and frequent awareness to how they program their own subjects and the programming trends of all enrolled subjects will change their programming patterns. This will be accomplished by understanding physicians' device programming behaviors and providing reports as a tool to help physicians manage their subjects and provide shock reduction programming recommended by previous publications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analysis cohort | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy Programming Report (TPR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Overall study (20 months on average) |
| Measure | Description | Time Frame |
|---|---|---|
| Lead Integrity Alert (LIA) Performance | Causes for LIA triggers reported during the study | Overall study (20 months on average) |
| Reasons for Inappropriate Shocks | Reasons for inappropriate shocks observed during the study |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects implanted with a Medtronic market released single, dual, or triple chamber defibrillator (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 are eligible for participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Marc Silver, M.D. | Raleigh Cardiology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31369873 | Derived | 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. |
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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%).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Analysis Cohort | Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Overall study (20 months on average) |
| Actions Taken Following a Shock | Characterization of actions taken by the subject immediately following a device shock | Overall study (20 months on average) |
| Barriers to Utilization of Shock Reduction Programming | Characterization of barriers to physician utilization of shock reduction programming | 24 months follow-up visit |
| Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | Characterization of shock reduction programming utilization by subject characteristics and geographical regions | Overall study (20 months on average) |
| Phoenix |
| Arizona |
| United States |
| Tucson | Arizona | United States |
| Hot Springs | Arkansas | United States |
| Little Rock | Arkansas | United States |
| Fremont | California | United States |
| Fresno | California | United States |
| Modesto | California | United States |
| Northridge | California | United States |
| Orange | California | United States |
| San Bernardino/Los Angeles | California | United States |
| Ventura | California | United States |
| New Haven | Connecticut | United States |
| Fort Lauderdale | Florida | United States |
| Jacksonville | Florida | United States |
| Ocala | Florida | United States |
| Palm Beach Gardens | Florida | United States |
| Pensacola | Florida | United States |
| Plantation | Florida | United States |
| Rockledge | Florida | United States |
| St. Petersburg | Florida | United States |
| Zephyrhills | Florida | United States |
| Atlanta | Georgia | United States |
| Berwyn | Illinois | United States |
| Elk Grove Village | Illinois | United States |
| Maywood | Illinois | United States |
| Evansville | Indiana | United States |
| Fort Wayne | Indiana | United States |
| Scarborough | Maine | United States |
| Baltimore | Maryland | United States |
| Takoma Park | Maryland | United States |
| New Bedford | Massachusetts | United States |
| Flint | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Lansing | Michigan | United States |
| Saint Joseph | Michigan | United States |
| Robbinsdale | Minnesota | United States |
| Saint Louis Park | Minnesota | United States |
| Jackson | Mississippi | United States |
| St Louis | Missouri | United States |
| Lincoln | Nebraska | United States |
| Las Vegas | Nevada | United States |
| Cherry Hill | New Jersey | United States |
| Clifton | New Jersey | United States |
| Flemington | New Jersey | United States |
| Newark | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Elmira | New York | United States |
| Flushing | New York | United States |
| New York | New York | United States |
| Utica | New York | United States |
| Williamsville | New York | United States |
| Charlotte | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Fargo | North Dakota | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Mansfield | Ohio | United States |
| Youngstown | Ohio | United States |
| Lawton | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Medford | Oregon | United States |
| Erie | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Wyomissing | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Chattanooga | Tennessee | United States |
| Nashville | Tennessee | United States |
| El Paso | Texas | United States |
| Fort Sam Houston | Texas | United States |
| Houston | Texas | United States |
| McAllen | Texas | United States |
| Tyler | Texas | United States |
| Charlottesville | Virginia | United States |
| Manassas | Virginia | United States |
| Charleston | West Virginia | United States |
| Morgantown | West Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Buenos Aires | Argentina |
| Adelaide | South Australia | Australia |
| Frankston | Victoria | Australia |
| Perth | Western Australia | Australia |
| Edmonton | Alberta | Canada |
| Victoria | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Kitchener | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Sherbrooke | Quebec | Canada |
| Guangzhou | Guangdong | China |
| Beijing | China |
| Kowloon | Hong Kong |
| New Dehli | National Capital Territory of Delhi | India |
| Sāket | New Dehli | India |
| Mexico City | Mexico |
| Frankton | Hamilton | New Zealand |
| Singapore | Singapore |
| Seoul | South Korea |
| Kaohsiung City | Taiwan |
| 12 Month Follow-up |
|
| 18 Month Follow-up |
|
| 24 Month Follow-up |
|
| COMPLETED |
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| NOT COMPLETED |
|
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Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects with paired baseline and follow-up programming data | Posted | Number | percentage of participants | Overall study (20 months on average) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lead Integrity Alert (LIA) Performance | Causes for LIA triggers reported during the study | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. | Posted | Number | percentage of subjects with LIA triggers | Overall study (20 months on average) | Subjects who experienced LIA triggers | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Reasons for Inappropriate Shocks | Reasons for inappropriate shocks observed during the study | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. | Posted | Number | percentage of inappropriate shocks | Overall study (20 months on average) | inappropriate shocks | Participants |
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| Secondary | Actions Taken Following a Shock | Characterization of actions taken by the subject immediately following a device shock | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. | Posted | Number | percentage of subjects with shocks | Overall study (20 months on average) | Subjects who experienced shocks | Participants |
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| Secondary | Barriers to Utilization of Shock Reduction Programming | Characterization of barriers to physician utilization of shock reduction programming | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. | Posted | Number | % of subjects not programmed to target | 24 months follow-up visit | Subjects not programmed to target | Participants |
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| Secondary | Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | Characterization of shock reduction programming utilization by subject characteristics and geographical regions | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution. | Posted | Number | percentage of participants | Overall study (20 months on average) |
|
|
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Adverse events were not collected in this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Analysis Cohort | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Lexcen, Clinical Research Specialist | Medtronic Cardiac Rhythm Disease Management | 763-526-9702 | daniel.lexcen@medtronic.com |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hong Kong |
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| Mexico |
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| Canada |
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| Argentina |
|
| Singapore |
|
| Australia |
|
| New Zealand |
|
| China |
|
| Korea, Republic of |
|
| India |
|
| Thailand |
|
| Title | Measurements |
|---|---|
|
| Increase in % on target (VF NID SP) |
|
| Increase in % on target (Wavelet) |
|
| Increase in % on target (PR Logic) |
|
| McNemar |
| <0.0001 |
| Increase in % on target (SVT Limit) |
| 6.8 |
| No |
| Superiority or Other |
| VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients. | McNemar | <0.0001 | Increase in % on target (VF NID PP) | 9.0 | No | Superiority or Other |
| VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients. | McNemar | 0.0116 | Increase in % on target (VF NID SP) | 3.5 | No | Superiority or Other |
| Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs. | McNemar | <0.0001 | Increase in % on target (Wavelet) | 9.5 | No | Superiority or Other |
| PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds. | McNemar | <0.0001 | Increase in % on target (PR Logic) | 3.2 | No | Superiority or Other |
| Subjects who experienced LIA triggers |
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| Subjects who experienced shocks |
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| Subjects not programmed to target |
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