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Medtronic Shock-Less Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00856349
First received: February 26, 2009
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
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:

MedlinePlus related topics: Shock
U.S. FDA Resources

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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT00856349

  Show 104 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Marc Silver, M.D. Raleigh Cardiology Associates
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on May 23, 2013