Medtronic Shock-Less Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management Identifier:
First received: February 26, 2009
Last updated: November 1, 2012
Last verified: November 2012

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.

Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Medtronic Shock-Less Study

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Proportion of subjects with changes in shock reduction programming from baseline to the end of follow-up. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lead Integrity Alert performance data. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Reasons for inappropriate shocks. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Barriers to utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Actions taken following a shock. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 4380
Study Start Date: April 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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
  Contacts and Locations
Please refer to this study by its identifier: NCT00856349

  Hide Study Locations
United States, Alabama
Anniston, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
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
United States, Connecticut
New Haven, Connecticut, United States
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
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Berwyn, Illinois, United States
Elk Grove Village, Illinois, United States
Maywood, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Fort Wayne, Indiana, United States
United States, Maine
Scarborough, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
Takoma Park, Maryland, United States
United States, Massachusetts
New Bedford, Massachusetts, United States
United States, Michigan
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
St. Joseph, Michigan, United States
United States, Minnesota
Robbinsdale, Minnesota, United States
St. Louis Park, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
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
United States, New Mexico
Albuquerque, New Mexico, United States
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
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
United States, North Dakota
Fargo, North Dakota, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Mansfield, Ohio, United States
Youngstown, Ohio, United States
United States, Oklahoma
Lawton, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
United States, Pennsylvania
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
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
United States, Virginia
Charlottesville, Virginia, United States
Manassas, Virginia, United States
United States, West Virginia
Charleston, West Virginia, United States
Morgantown, West Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Buenos Aires, Argentina
Australia, South Australia
Adelaide, South Australia, Australia
Australia, Victoria
Frankston, Victoria, Australia
Australia, Western Australia
Perth, Western Australia, Australia
Canada, Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Kitchener, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montréal, Quebec, Canada
Sherbrooke, Quebec, Canada
China, Guangdong
Guangzhou, Guangdong, China
Beijing, China
Hong Kong
Kowloon, Hong Kong
New Dehli, Delhi, India
Saket, New Dehli, India
Korea, Republic of
Seoul, Korea, Republic of
Mexico City, Mexico
New Zealand
Frankton, Hamilton, New Zealand
Singapore, Singapore
Kaohsiung, Taiwan
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Principal Investigator: Marc Silver, M.D. Raleigh Cardiology Associates
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management Identifier: NCT00856349     History of Changes
Other Study ID Numbers: Shock-Less
Study First Received: February 26, 2009
Last Updated: November 1, 2012
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

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Lead Integrity Alert

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on April 16, 2014