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

July 1, 2014 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

4384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • Frankston, Victoria, Australia
    • Western Australia
      • Perth, Western Australia, Australia
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Victoria, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Kitchener, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montréal, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • China
      • Beijing, China
    • Guangdong
      • Guangzhou, Guangdong, China
  • Hong Kong
      • Kowloon, Hong Kong
  • India
    • Delhi
      • New Dehli, Delhi, India
    • New Dehli
      • Saket, New Dehli, India
  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Mexico
      • Mexico City, Mexico
  • New Zealand
    • Hamilton
      • Frankton, Hamilton, New Zealand
  • Singapore
      • Singapore, Singapore
  • Taiwan
      • Kaohsiung, Taiwan
  • United States
    • Alabama
      • Anniston, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • 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
    • Connecticut
      • New Haven, Connecticut, United States
    • Florida
      • 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
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Berwyn, Illinois, United States
      • Elk Grove Village, Illinois, United States
      • Maywood, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Fort Wayne, Indiana, United States
    • Maine
      • Scarborough, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • New Bedford, Massachusetts, United States
    • Michigan
      • Flint, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
      • St. Joseph, Michigan, United States
    • Minnesota
      • Robbinsdale, Minnesota, United States
      • St. Louis Park, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Clifton, New Jersey, United States
      • Flemington, New Jersey, United States
      • Newark, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • 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
    • North Carolina
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Mansfield, Ohio, United States
      • Youngstown, Ohio, United States
    • Oklahoma
      • Lawton, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Erie, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Wyomissing, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • El Paso, Texas, United States
      • Fort Sam Houston, Texas, United States
      • Houston, Texas, United States
      • Mc Allen, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Manassas, Virginia, United States
    • West Virginia
      • Charleston, West Virginia, United States
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Shock Reduction Programming Adoption
Time Frame: Overall study (20 months on average)

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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead Integrity Alert (LIA) Performance
Time Frame: Overall study (20 months on average)
Causes for LIA triggers reported during the study
Overall study (20 months on average)
Reasons for Inappropriate Shocks
Time Frame: Overall study (20 months on average)
Reasons for inappropriate shocks observed during the study
Overall study (20 months on average)
Actions Taken Following a Shock
Time Frame: Overall study (20 months on average)
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
Time Frame: 24 months follow-up visit
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
Time Frame: Overall study (20 months on average)
Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Overall study (20 months on average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: Marc Silver, M.D., Raleigh Cardiology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shock-Less

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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