Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming

NCT ID: NCT00856349

Last Updated: 2014-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Analysis cohort

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

Therapy Programming Report (TPR)

Intervention Type 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.

Interventions

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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 Type BEHAVIORAL

Eligibility Criteria

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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

Exclusion Criteria

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Silver, M.D.

Role: PRINCIPAL_INVESTIGATOR

Raleigh Cardiology Associates

Locations

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Anniston, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Fremont, California, United States

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Fresno, California, United States

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Modesto, California, United States

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Northridge, California, United States

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Orange, California, United States

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San Bernardino/Los Angeles, California, United States

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Ventura, California, United States

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New Haven, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Ocala, Florida, United States

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Palm Beach Gardens, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Rockledge, Florida, United States

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St. Petersburg, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Berwyn, Illinois, United States

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Elk Grove Village, Illinois, United States

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Maywood, Illinois, United States

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Evansville, Indiana, United States

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Fort Wayne, Indiana, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Takoma Park, Maryland, United States

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New Bedford, Massachusetts, United States

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Flint, Michigan, United States

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Kalamazoo, Michigan, United States

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Lansing, Michigan, United States

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Saint Joseph, Michigan, United States

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Robbinsdale, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Clifton, New Jersey, United States

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Flemington, New Jersey, United States

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Newark, New Jersey, United States

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Albuquerque, New Mexico, United States

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Elmira, New York, United States

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Flushing, New York, United States

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New York, New York, United States

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Utica, New York, United States

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Williamsville, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Mansfield, Ohio, United States

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Youngstown, Ohio, United States

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Lawton, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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El Paso, Texas, United States

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Fort Sam Houston, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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Tyler, Texas, United States

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Charlottesville, Virginia, United States

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Manassas, Virginia, United States

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Charleston, West Virginia, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Adelaide, South Australia, Australia

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Frankston, Victoria, Australia

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Perth, Western Australia, Australia

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Edmonton, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Kitchener, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Guangzhou, Guangdong, China

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Beijing, , China

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Kowloon, , Hong Kong

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New Dehli, National Capital Territory of Delhi, India

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Sāket, New Dehli, India

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Mexico City, , Mexico

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Frankton, Hamilton, New Zealand

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Singapore, , Singapore

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Seoul, , South Korea

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Kaohsiung City, , Taiwan

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Countries

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United States Argentina Australia Canada China Hong Kong India Mexico New Zealand Singapore South Korea Taiwan

References

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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.

Reference Type DERIVED
PMID: 31369873 (View on PubMed)

Other Identifiers

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Shock-Less

Identifier Type: -

Identifier Source: org_study_id

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