Status:
COMPLETED
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
Brief Summary
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 prog...
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 re...
Eligibility Criteria
Inclusion
- 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
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
4384 Patients enrolled
Trial Details
Trial ID
NCT00856349
Start Date
April 1 2009
End Date
March 1 2013
Last Update
July 3 2014
Active Locations (104)
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1
Anniston, Alabama, United States
2
Phoenix, Arizona, United States
3
Tucson, Arizona, United States
4
Hot Springs, Arkansas, United States